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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72979

5 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 21, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Ortho-Clinical Diagnostics

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

5 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 5

VITROS 250 Chemistry Systems, Catalog 8132086, Unique Device Identifier No. 10758750004409, and VITROS 250 Refurbished, Catalog 6801759, Unique Device Identifier No. 10758750001330; IVD. Product Usage: For in vitro diagnostic use. The VITROS 250 Chemistry System performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.

Z-1071-2016
Recall number
Z-1071-2016
Initiated
December 21, 2015
Classification
Class II
Status
Terminated
Quantity
US: 802; Foreign: 2472

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954. A trend of complaints regarding customers actions following U90-382 or 6LU condition codes was noted (See RES 72289 - VITROS Calibrator Kit 9, lot 954 recall).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954. A trend of complaints regarding customers actions following U90-382 or 6LU condition codes was noted (See RES 72289 - VITROS Calibrator Kit 9, lot 954 recall).

Code information

Software Version 9.4 and below; VITROS 250 Serial Numbers: 25010043 - 25055306; VITROS 250 Refurbished Serial Numbers: 25010582, 25010617, 25010638, 25010782, 25011056, 25011074, 25011176, 25011192, 25011196, 25011246, 25011317, 25011383, 25011408, 25011435, 25011448, 25011517, 25011647, 25011648, 25011777, 25011957, 25012025, 25012058, 25012062, 25012073, 25012078, 25012140, 25012259, 25012267, 25012323, 25012344, 25012487, 25012505, 25012521, 25012574, 25012629, 25012654, 25012672, 25012765, 25012782, 25012838, 25012931, 25012938, 25013036, 25013100, 25013139, 25013216, 25013245, 25013313, 25013389, 25013391, 25013448, 25013473, 25013497, 25013583, 25013597, 25013719, 25013757, 25013787, 25013790, 25013870, 25013879, 25013971, 25013982, 25014033, 25014196, 25014201, 25014209, 25014272, 25014278, 25014286, 25014318, 25014404, 25014409, 25014412, 25014448, 25014449, 25014459, 25014562, 25014609, 25014610, 25014655, 25014657, 25014663, 25014728, 25014741, 25014775, 25014788, 25014832, 25014849, 25014927, 25015076, 25015132, 25015133, 25015169, 25015223, 25015242, 25015277, 25015389, 25015430, 25015445, 25015463, 25015678, 25015770, 25015847, 25015914, 25015915, 25015976, 25015990, 25015998, 25016011, 25016177, 25016218, 25016429, 25016463, 25016517, 25016528, 25016552, 27000025, 27000054, 27000132, 27000156, 27000216, 27000317, 27000488, 27000870, 27000936, 27001058, 27001124, 27001471, 27001644, 27001651, 27001763, 27002256, 27002351, 27002714, R2500159, R2500179, R2500217, 25010122, 25010187, 25010220, 25010320, 25010332, 25010360, 25010362, 25010380, 25010394, 25010429, 25010450, 25010465, 25010522, 25010584, 25010648, 25010677, 25010690, 25010691, 25010694, 25010697, 25010709, 25010713, 25010719, 25010725, 25010735, 25010749, 25010751, 25010753, 25010770, 25010772, 25010774, 25010775, 25010802, 25010809, 25010817, 25010841, 25010845, 25010848, 25010850, 25010859, 25010864, 25010865, 25010867, 25010872, 25010885, 25010889, 25010908, 25010919, 25010923, 25010949, 25010954, 25010955, 25010962, 25010965, 25010970, 25010996, 25011018, 25011030, 25011031, 25011043, 25011061, 25011072, 25011078, 25011083, 25011107, 25011109, 25011126, 25011131, 25011133, 25011161, 25011179, 25011187, 25011205, 25011208, 25011230, 25011231, 25011243, 25011247, 25011255, 25011256, 25011274, 25011278, 25011283, 25011324, 25011341, 25011345, 25011356, 25011361, 25011362, 25011372, 25011384, 25011385, 25011388, 25011390, 25011392, 25011393, 25011407, 25011424, 25011436, 25011441, 25011446, 25011456, 25011462, 25011466, 25011473, 25011476, 25011479, 25011482, 25011500, 25011501, 25011508, 25011513, 25011521, 25011525, 25011533, 25011535, 25011541, 25011553, 25011556, 25011565, 25011569, 25011599, 25011610, 25011619, 25011624, 25011627, 25011631, 25011649, 25011650, 25011673, 25011678, 25011679, 25011684, 25011698, 25011701, 25011709, 25011710, 25011712, 25011719, 25011729, 25011732, 25011743, 25011749, 25011751, 25011759, 25011780, 25011783, 25011785, 25011795, 25011797, 25011816, 25011817, 25011826, 25011834, 25011836, 25011845, 25011852, 25011854, 25011868, 25011872, 25011878, 25011880, 25011881, 25011887, 25011891, 25011900, 25011904, 25011922, 25011937, 25011940, 25011949, 25011956, 25011960, 25011964, 25011965, 25011966, 25011968, 25011983, 25011985, 25011987, 25011988, 25012001, 25012002, 25012004, 25012015, 25012016, 25012017, 25012024, 25012029, 25012042, 25012043, 25012044, 25012052, 25012053, 25012056, 25012065, 25012066, 25012074, 25012087, 25012090, 25012102, 25012105, 25012111, 25012115, 25012118, 25012127, 25012134, 25012155, 25012169, 25012192, 25012193, 25012196, 25012221, 25012227, 25012231, 25012242, 25012262, 25012264, 25012270, 25012274, 25012283, 25012298, 25012301, 25012302, 25012310, 25012312, 25012313, 25012325, 25012336, 25012351, 25012357, 25012360, 25012371, 25012379, 25012380, 25012391, 25012404, 25012411, 25012418, 25012421, 25012422, 25012429, 25012431, 25012436, 25012444, 25012445, 25012464, 25012467, 25012478, 25012479, 25012480, 25012481, 25012482, 25012483, 25012485, 25012489, 25012494, 25012504, 25012506, 25012511, 25012512, 25012514, 25012525, 25012545, 25012547, 25012552, 25012579, 25012582, 25012597, 25012614, 25012624, 25012626, 25012628, 25012641, 25012648, 25012651, 25012652, 25012653, 25012655, 25012656, 25012657, 25012658, 25012660, 25012661, 25012663, 25012680, 25012707, 25012710, 25012718, 25012723, 25012726, 25012728, 25012733, 25012735, 25012736, 25012742, 25012751, 25012775, 25012779, 25012784, 25012786, 25012791, 25012793, 25012803, 25012806, 25012808, 25012821, 25012836, 25012843, 25012861, 25012878, 25012879, 25012883, 25012886, 25012888, 25012897, 25012903, 25012906, 25012914, 25012921, 25012924, 25012927, 25012930, 25012937, 25012939, 25012941, 25012943, 25012950, 25012951, 25012952, 25012956, 25012966, 25012971, 25012974, 25012976, 25012985, 25012988, 25012995, 25013001, 25013002, 25013006, 25013009, 25013010, 25013015, 25013019, 25013020, 25013021, 25013025, 25013033, 25013037, 25013042, 25013045, 25013054, 25013063, 25013068, 25013073, 25013074, 25013075, 25013091, 25013110, 25013114, 25013119, 25013124, 25013151, 25013155, 25013157, 25013174, 25013185, 25013205, 25013207, 25013210, 25013219, 25013222, 25013230, 25013236, 25013239, 25013241, 25013244, 25013248, 25013258, 25013265, 25013272, 25013273, 25013278, 25013279, 25013282, 25013284, 25013297, 25013303, 25013312, 25013314, 25013315, 25013316, 25013318, 25013331, 25013332, 25013334, 25013335, 25013336, 25013354, 25013362, 25013364, 25013374, 25013376, 25013383, 25013386, 25013388, 25013393, 25013398, 25013413, 25013416, 25013424, 25013440, 25013441, 25013443, 25013444, 25013456, 25013459, 25013472, 25013478, 25013483, 25013484, 25013488, 25013491, 25013492, 25013496, 25013505, 25013508, 25013511, 25013522, 25013531, 25013539, 25013544, 25013545, 25013549, 25013558, 25013559, 25013561, 25013562, 25013563, 25013564, 25013568, 25013573, 25013580, 25013581, 25013582, 25013584, 25013589, 25013592, 25013599, 25013601, 25013603, 25013612, 25013615, 25013617, 25013622, 25013623, 25013631, 25013632, 25013637, 25013659, 25013662, 25013665, 25013666, 25013668, 25013669, 25013670, 25013673, 25013675, 25013679, 25013689, 25013693, 25013694, 25013697, 25013707, 25013713, 25013715, 25013717, 25013718, 25013732, 25013733, 25013736, 25013737, 25013739, 25013747, 25013755, 25013766, 25013772, 25013773, 25013775, 25013776, 25013779, 25013793, 25013812, 25013814, 25013820, 25013824, 25013825, 25013826, 25013834, 25013840, 25013844, 25013847, 25013859, 25013862, 25013867, 25013869, 25013873, 25013876, 25013878, 25013881, 25013882, 25013887, 25013888, 25013890, 25013894, 25013900, 25013904, 25013907, 25013908, 25013909, 25013915, 25013916, 25013917, 25013932, 25013935, 25013938, 25013940, 25013945, 25013954, 25013957, 25013958, 25013959, 25013967, 25013968, 25013969, 25013972, 25013979, 25013980, 25013987, 25013988, 25013989, 25013994, 25014011, 25014012, 25014016, 25014020, 25014024, 25014031, 25014037, 25014047, 25014050, 25014051, 25014055, 25014057, 25014060, 25014065, 25014067, 25014072, 25014074, 25014087, 25014093, 25014097, 25014100, 25014109, 25014119, 25014121, 25014126, 25014127, 25014129, 25014130, 25014131, 25014137, 25014149, 25014155, 25014169, 25014172, 25014173, 25014174, 25014182, 25014191, 25014193, 25014194, 25014199, 25014211, 25014222, 25014223, 25014226, 25014236, 25014239, 25014244, 25014245, 25014250, 25014252, 25014260, 25014263, 25014265, 25014274, 25014276, 25014277, 25014279, 25014281, 25014288, 25014309, 25014310, 25014311, 25014319, 25014322, 25014325, 25014330, 25014343, 25014357, 25014366, 25014376, 25014378, 25014380, 25014384, 25014386, 25014390, 25014391, 25014392, 25014425, 25014426, 25014432, 25014435, 25014441, 25014452, 25014467, 25014468, 25014469, 25014477, 25014479, 25014489, 25014503, 25014507, 25014517, 25014518, 25014529, 25014539, 25014541, 25014551, 25014566, 25014567, 25014573, 25014578, 25014580, 25014582, 25014603, 25014604, 25014613, 25014617, 25014620, 25014627, 25014628, 25014630, 25014631, 25014638, 25014650, 25014654, 25014674, 25014677, 25014696, 25014697, 25014707, 25014714, 25014715, 25014716, 25014717, 25014719, 25014725, 25014730, 25014737, 25014738, 25014739, 25014747, 25014763, 25014765, 25014767, 25014769, 25014771, 25014783, 25014787, 25014789, 25014796, 25014805, 25014807, 25014821, 25014823, 25014824, 25014826, 25014827, 25014831, 25014834, 25014838, 25014840, 25014841, 25014843, 25014844, 25014851, 25014855, 25014856, 25014857, 25014858, 25014865, 25014866, 25014877, 25014878, 25014886, 25014887, 25014888, 25014889, 25014893, 25014896, 25014899, 25014902, 25014905, 25014908, 25014923, 25014924, 25014935, 25014938, 25014939, 25014940, 25014942, 25014947, 25014951, 25014952, 25014958, 25014970, 25014973, 25014974, 25014977, 25014979, 25014984, 25014986, 25014992, 25014994, 25014995, 25014998, 25015004, 25015013, 25015014, 25015019, 25015029, 25015031, 25015039, 25015042, 25015044, 25015048, 25015053, 25015055, 25015063, 25015068, 25015075, 25015086, 25015090, 25015093, 25015099, 25015105, 25015108, 25015112, 25015120, 25015126, 25015137, 25015139, 25015140, 25015141, 25015147, 25015160, 25015161, 25015165, 25015171, 25015192, 25015205, 25015215, 25015216, 25015218, 25015225, 25015231, 25015235, 25015236, 25015239, 25015240, 25015249, 25015256, 25015257, 25015259, 25015261, 25015267, 25015274, 25015284, 25015291, 25015293, 25015294, 25015296, 25015299, 25015307, 25015310, 25015311, 25015318, 25015319, 25015321, 25015323, 25015326, 25015338, 25015339, 25015342, 25015350, 25015351, 25015353, 25015354, 25015355, 25015358, 25015359, 25015360, 25015367, 25015372, 25015373, 25015378, 25015381, 25015382, 25015386, 25015387, 25015393, 25015404, 25015405, 25015408, 25015413, 25015415, 25015416, 25015424, 25015425, 25015433, 25015435, 25015441, 25015452, 25015467, 25015477, 25015483, 25015484, 25015487, 25015503, 25015513, 25015518, 25015521, 25015529, 25015559, 25015566, 25015577, 25015578, 25015585, 25015589, 25015590, 25015597, 25015600, 25015603, 25015610, 25015611, 25015612, 25015614, 25015625, 25015633, 25015634, 25015639, 25015641, 25015644, 25015645, 25015650, 25015654, 25015658, 25015661, 25015670, 25015671, 25015674, 25015676, 25015682, 25015685, 25015690, 25015699, 25015702, 25015704, 25015705, 25015710, 25015712, 25015713, 25015717, 25015723, 25015734, 25015736, 25015739, 25015741, 25015742, 25015757, 25015763, 25015764, 25015765, 25015782, 25015783, 25015787, 25015788, 25015789, 25015803, 25015807, 25015808, 25015811, 25015812, 25015814, 25015817, 25015824, 25015825, 25015837, 25015842, 25015846, 25015851, 25015856, 25015859, 25015860, 25015863, 25015871, 25015874, 25015875, 25015878, 25015879, 25015882, 25015889, 25015894, 25015898, 25015904, 25015912, 25015913, 25015923, 25015924, 25015935, 25015938, 25015946, 25015958, 25015963, 25015965, 25015969, 25015970, 25015973, 25015981, 25015983, 25015985, 25016000, 25016009, 25016012, 25016019, 25016021, 25016030, 25016037, 25016039, 25016041, 25016045, 25016048, 25016049, 25016051, 25016053, 25016054, 25016058, 25016063, 25016069, 25016073, 25016086, 25016087, 25016088, 25016095, 25016102, 25016104, 25016108, 25016113, 25016115, 25016116, 25016118, 25016120, 25016126, 25016128, 25016142, 25016149, 25016151, 25016159, 25016164, 25016172, 25016176, 25016181, 25016215, 25016231, 25016234, 25016240, 25016241, 25016242, 25016255, 25016268, 25016273, 25016276, 25016290, 25016298, 25016299, 25016301, 25016305, 25016309, 25016316, 25016324, 25016325, 25016333, 25016337, 25016357, 25016360, 25016361, 25016368, 25016384, 25016391, 25016392, 25016404, 25016407, 25016411, 25016414, 25016418, 25016426, 25016428, 25016431, 25016433, 25016437, 25016441, 25016443, 25016446, 25016452, 25016453, 25016458, 25016461, 25016467, 25016474, 25016479, 25016480, 25016486, 25016490, 25016492, 25016494, 25016495, 25016497, 25016511, 25016514, 25016524, 25016549, 25016551, 25016556, 25016557, 25016558, 25016563, 25016566, 25016573, 25016580, 25016582, 25016586, 25016589, 25016594, 25016595, 25016596, 25016602, 25016604, 25016613, 25016619, 25016620, 25016637, 25016638, 25016644, 25016647, 25016649, 25016650, 25016670, 25016804, 25016818, 25016837, 25016838, 25016852, 25016899, 25016912, 25016916, 25016917, 25016918, 25016919, 25016932, 25016940, 25016943, 25016944, 25016946, 25016947, 25016950, 25016951, 25016952, 25016953, 25016957, 25016958, 25104774, 27000004, 27000006, 27000007, 27000008, 27000009, 27000010, 27000016, 27000018, 27000022, 27000041, 27000051, 27000052, 27000058, 27000061, 27000063, 27000070, 27000072, 27000075, 27000080, 27000089, 27000103, 27000106, 27000110, 27000112, 27000115, 27000126, 27000133, 27000134, 27000135, 27000136, 27000146, 27000147, 27000148, 27000164, 27000165, 27000175, 27000181, 27000183, 27000192, 27000203, 27000205, 27000206, 27000208, 27000209, 27000217, 27000223, 27000224, 27000227, 27000233, 27000244, 27000273, 27000281, 27000287, 27000289, 27000290, 27000300, 27000303, 27000304, 27000309, 27000313, 27000316, 27000324, 27000326, 27000328, 27000333, 27000350, 27000351, 27000355, 27000357, 27000362, 27000369, 27000372, 27000373, 27000374, 27000382, 27000383, 27000384, 27000389, 27000409, 27000415, 27000418, 27000421, 27000424, 27000427, 27000436, 27000448, 27000450, 27000453, 27000456, 27000457, 27000467, 27000470, 27000471, 27000477, 27000479, 27000483, 27000484, 27000489, 27000492, 27000507, 27000515, 27000516, 27000529, 27000538, 27000540, 27000546, 27000568, 27000581, 27000584, 27000598, 27000606, 27000607, 27000624, 27000627, 27000652, 27000655, 27000658, 27000660, 27000662, 27000663, 27000677, 27000678, 27000680, 27000683, 27000686, 27000696, 27000709, 27000713, 27000714, 27000716, 27000717, 27000718, 27000719, 27000740, 27000745, 27000758, 27000769, 27000777, 27000779, 27000784, 27000787, 27000790, 27000791, 27000796, 27000797, 27000806, 27000813, 27000814, 27000824, 27000835, 27000847, 27000854, 27000861, 27000862, 27000869, 27000872, 27000873, 27000874, 27000875, 27000877, 27000880, 27000881, 27000882, 27000894, 27000903, 27000908, 27000912, 27000924, 27000926, 27000927, 27000928, 27000930, 27000947, 27000948, 27000949, 27000958, 27000961, 27000963, 27000964, 27000984, 27000988, 27000994, 27001005, 27001006, 27001007, 27001021, 27001032, 27001061, 27001066, 27001087, 27001089, 27001091, 27001093, 27001094, 27001103, 27001104, 27001123, 27001139, 27001144, 27001145, 27001166, 27001167, 27001170, 27001177, 27001183, 27001185, 27001187, 27001193, 27001202, 27001205, 27001212, 27001213, 27001221, 27001223, 27001229, 27001234, 27001236, 27001240, 27001241, 27001279, 27001283, 27001289, 27001304, 27001319, 27001326, 27001334, 27001337, 27001353, 27001360, 27001361, 27001364, 27001366, 27001381, 27001400, 27001402, 27001418, 27001426, 27001429, 27001434, 27001448, 27001473, 27001497, 27001520, 27001524, 27001525, 27001526, 27001531, 27001533, 27001535, 27001552, 27001556, 27001559, 27001565, 27001599, 27001612, 27001639, 27001645, 27001646, 27001647, 27001660, 27001662, 27001667, 27001670, 27001692, 27001693, 27001694, 27001696, 27001698, 27001729, 27001741, 27001766, 27001772, 27001785, 27001796, 27001802, 27001806, 27001871, 27001901, 27001905, 27001912, 27001934, 27001952, 27001953, 27001968, 27001975, 27002013, 27002018, 27002028, 27002044, 27002134, 27002136, 27002151, 27002183, 27002245, 27002304, 27002350, 27002352, 27002521, 27002526, 27002557, 27002652, 27002663, 25010717A, R2500004, R2500011, R2500028, R2500033, R2500037, R2500041, R2500044, R2500050, R2500063, R2500081, R2500087, R2500125, R2500140, R2500146, R2500147, R2500149, R2500155, R2500158, R2500173, R2500183, R2500188, R2500189, R2500191, R2500232

Distribution pattern

Worldwide Distribution - US Nationwide including Puerto Rico, and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela

device · product 2 of 5

VITROS 350 Chemistry System, Catalog Number 6802153, Unique Device Identifier Number 10758750002054; IVD. Product Usage: For in vitro diagnostic use. The VITROS 350 Chemistry System performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.

Z-1072-2016
Recall number
Z-1072-2016
Initiated
December 21, 2015
Classification
Class II
Status
Terminated
Quantity
US = 885; Foreign: 3221

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954. A trend of complaints regarding customers actions following U90-382 or 6LU condition codes was noted (See RES 72289 - VITROS Calibrator Kit 9, lot 954 recall).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954. A trend of complaints regarding customers actions following U90-382 or 6LU condition codes was noted (See RES 72289 - VITROS Calibrator Kit 9, lot 954 recall).

Code information

Software Version 9.4 and below; Serial Numbers J27000001 - 27004539

Distribution pattern

Worldwide Distribution - US Nationwide including Puerto Rico, and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela

device · product 3 of 5

VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343; IVD. Product Usage: For in vitro diagnostic use. The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.)

Z-1073-2016
Recall number
Z-1073-2016
Initiated
December 21, 2015
Classification
Class II
Status
Terminated
Quantity
US = 163; Foreign = 286

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954. A trend of complaints regarding customers actions following U90-382 or 6LU condition codes was noted (See RES 72289 - VITROS Calibrator Kit 9, lot 954 recall).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954. A trend of complaints regarding customers actions following U90-382 or 6LU condition codes was noted (See RES 72289 - VITROS Calibrator Kit 9, lot 954 recall).

Code information

Software Version 3.2 and below; Serial Numbers J46000001 - 46000678

Distribution pattern

Worldwide Distribution - US Nationwide including Puerto Rico, and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela

device · product 4 of 5

VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750002740; IVD. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.

Z-1074-2016
Recall number
Z-1074-2016
Initiated
December 21, 2015
Classification
Class II
Status
Terminated
Quantity
US = 1009; Foreign = 1003

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954. A trend of complaints regarding customers actions following U90-382 or 6LU condition codes was noted (See RES 72289 - VITROS Calibrator Kit 9, lot 954 recall).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954. A trend of complaints regarding customers actions following U90-382 or 6LU condition codes was noted (See RES 72289 - VITROS Calibrator Kit 9, lot 954 recall).

Code information

Software Version 3.2 and below; Serial Numbers J56000024 - 56002339

Distribution pattern

Worldwide Distribution - US Nationwide including Puerto Rico, and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela

device · product 5 of 5

VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132; and VITROS 5,1 FS Chemistry System (Refurbished), Catalog Number 6801890, Unique Device Identifier Number 10758750001644; IVD. Product Usage: The VITROS 5,1 FS Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.)

Z-1075-2016
Recall number
Z-1075-2016
Initiated
December 21, 2015
Classification
Class II
Status
Terminated
Quantity
US = 994; Foreign = 1405

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954. A trend of complaints regarding customers actions following U90-382 or 6LU condition codes was noted (See RES 72289 - VITROS Calibrator Kit 9, lot 954 recall).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954. A trend of complaints regarding customers actions following U90-382 or 6LU condition codes was noted (See RES 72289 - VITROS Calibrator Kit 9, lot 954 recall).

Code information

Software Version 2.8 and below; VITROS 5,1 FS Chemistry System Serial Numbers: J34000119 - J34002323; VITROS 5,1 FS Chemistry System (Refurbished) Serial Numbers: 34000133, 34000193, 34000197, 34000212, 34000285, 34000316, 34000318, 34000337, 34000360, 34000420, 34000451, 34000478, 34000495, 34000497, 34000529, 34000538, 34000552, 34000557, 34000590, 34000596, 34000601, 34000631, 34000642, 34000761, 34000799, 34000805, 34000833, 34000851, 34000893, 34000946, 34000947, 34001006, 34001172, 34001218, 34001240, 34001243, 34001248, 34001251, 34001274, 34001297, 34001317, 34001345, 34001378, 34001379, 34001389, 34001390, 34001396, 34001422, 34001472, 34001504, 34001569, 34001572, 34001612, 34001626, 34001633, 34001668, 34001755, 34001809, 34001840, 34001850, 34001875, 34001897, 34000123, 34000143, 34000191, 34000215, 34000219, 34000235, 34000251, 34000256, 34000260, 34000261, 34000319, 34000331, 34000380, 34000382, 34000406, 34000408, 34000412, 34000426, 34000431, 34000454, 34000464, 34000473, 34000501, 34000523, 34000530, 34000541, 34000542, 34000546, 34000548, 34000553, 34000558, 34000576, 34000577, 34000584, 34000585, 34000609, 34000612, 34000615, 34000616, 34000617, 34000618, 34000620, 34000625, 34000637, 34000644, 34000672, 34000744, 34000745, 34000755, 34000759, 34000767, 34000776, 34000793, 34000800, 34000814, 34000831, 34000844, 34000846, 34000852, 34000856, 34000870, 34000876, 34000887, 34000892, 34000902, 34000912, 34000920, 34000938, 34000956, 34000969, 34000976, 34001007, 34001009, 34001044, 34001045, 34001052, 34001071, 34001075, 34001098, 34001099, 34001111, 34001129, 34001154, 34001161, 34001171, 34001182, 34001192, 34001195, 34001201, 34001204, 34001208, 34001212, 34001234, 34001247, 34001254, 34001271, 34001278, 34001284, 34001288, 34001289, 34001293, 34001298, 34001301, 34001302, 34001316, 34001325, 34001337, 34001340, 34001348, 34001367, 34001369, 34001399, 34001400, 34001407, 34001410, 34001416, 34001423, 34001427, 34001429, 34001457, 34001490, 34001518, 34001526, 34001551, 34001573, 34001580, 34001581, 34001582, 34001587, 34001589, 34001594, 34001610, 34001618, 34001623, 34001627, 34001673, 34001688, 34001693, 34001725, 34001738, 34001745, 34001747, 34001790, 34001796, 34001798, 34001810, 34001822, 34001831, 34001833, 34001849, 34001855, 34001859, 34001860, 34001867, 34001871, 34001872, 34001881, 34001905, 34001916, 34001923, 34001995

Distribution pattern

Worldwide Distribution - US Nationwide including Puerto Rico, and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela