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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79271

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 15, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Quidel Corporation

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

1 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 1

Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer intended to be used with Cassette-based immunofluorescent in vitro diagnostic assays . Sofia 2 is intended for professional and laboratory use.

Z-1183-2018
Recall number
Z-1183-2018
Initiated
December 15, 2017
Classification
Class II
Status
Terminated
Recalling firm
Quidel Corporation
Quantity
482 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing process which may lead to a failure

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Manufacturing/Software Deployment

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The calibration for the affected batch of analyzers was incorrectly set during the manufacturing process which may lead to a failure when calibration is first performed. There may also be e remote possibility that incorrect qualitative test results for patient samples near the assay cutoff may be reported.

Code information

Serial Numbers: 29003956, 29004025, 29004086, 29004072, 29004188, 29004150, 29004229, 29004127, 29004232, 29004204, 29004256, 29004362, 29004155, 29004290, 29004329, 29004347, 29004350, 29004353, 29004370, 29004390, 29004396, 29004415, 29003381, 29003814, 29004183, 29004259, 29004263, 29004281, 29004317, 29004343, 29004205, 29004209, 29004001, 29004062, 29004077, 29003915, 29004036, 29004057, 29003979, 29004085, 29004144, 29004267, 29004322, 29003960, 29003991, 29004163, 29004190, 29004330, 29003992, 29004033, 29003987, 29004306, 29004325, 29004332, 29004066, 29004335, 29004373, 29004430, 29004223, 29004299, 29003999, 29004026, 29004069, 29003811, 29004164, 29004189, 29004226, 29003923, 29004160, 29004206, 29004181, 29004194, 29003584, 29004172, 29004014, 29004046, 29004352, 29004354, 29004376, 29004285, 29004377, 29004016, 29004047, 29004054, 29004196, 29003970, 29004173, 29004372, 29004252, 29004287, 29004311, 29004159, 29004356, 29004381, 29004089, 29004092, 29004270, 29004331, 29004357, 29004413, 29003578, 29004250, 29003967, 29004235, 29004319, 29003928, 29004096, 29004262, 29004280, 29004273, 29004302, 29004284, 29004278, 29004241, 29004305, 29004067, 29004125, 29004228, 29004265, 29004097, 29004303, 29004342, 29004349, 29004286, 29004098, 29004108, 29004128, 29004130, 29003947, 29004037, 29003961, 29004408, 29003636, 29003990, 29004240, 29004215, 29003738, 29004093, 29004070, 29003635, 29004006, 29004011, 29004015, 29004061, 29004073, 29004088, 29004106, 29004142, 29004148, 29004161, 29004162, 29004351, 29004391, 29004418, 29004146, 29004170, 29003978, 29004123, 29004208, 29004249, 29004315, 29004407, 29004111, 29004116, 29004243, 29004469, 29004511, 29004535, 29004548, 29003977, 29004187, 29004018, 29004039, 29004052, 29004009, 29003952, 29002222, 29004230, 29003957, 29003965, 29004359, 29004346, 29004361, 29004369, 29004378, 29004387, 29004411, 29004393, 29004441, 29004443, 29003769, 29003840, 29004147, 29004156, 29004176, 29004184, 29004186, 29004192, 29004202, 29004203, 29004210, 29004214, 29004216, 29004219, 29004222, 29004225, 29004227, 29003980, 29004048, 29004064, 29004304, 29004423, 29004283, 29004295, 29004297, 29004298, 29004310, 29004392, 29004224, 29004231, 29004558, 29004076, 29004165, 29004414, 29004274, 29004292, 29004300, 29004314, 29004318, 29004041, 29004101, 29004334, 29004380, 29004074, 29003886, 29004023, 29004081, 29004402, 29003892, 29004211, 29003936, 29004003, 29004404, 29003703, 29004153, 29004191, 29004213, 29004100, 29004040, 29004333, 29004336, 29004367, 29004291, 29004338, 29004288, 29004365, 29004239, 29004337, 29004486, 29004504, 29004508, 29004519, 29004524, 29003891, 29002538, 29004242, 29004174, 29003971, 29004012, 29003617, 29003975, 29003973, 29004145, 29003700, 29004133, 29004275, 29004326, 29004339, 29004307, 29004233, 29004257, 29004282, 29004296, 29004309, 29004323, 29004084, 29004234, 29004238, 29004254, 29004260, 29004261, 29004316, 29004447, 29004503, 29004533, 29004545, 29004552, 29004143, 29004197, 29004151, 29002356, 29002457, 29003946, 29003948, 29004017, 29004045, 29004095, 29004102, 29004104, 29004107, 29004110, 29004134, 29004137, 29004152, 29004157, 29004022, 29004382, 29004434, 29004027, 29003989, 29003995, 29004035, 29004087, 29004090, 29003993, 29004105, 29004114, 29004279, 29003688, 29004131, 29004139, 29004374, 29004360, 29004368, 29004375, 29004371, 29003731, 29004397, 29004328, 29004388, 29004010, 29004177, 29004348, 29004355, 29004366, 29004383, 29004399, 29004422, 29004425, 29004432, 29004440, 29004294, 29002598, 29003969, 29004112, 29004117, 29004412, 29004416, 29004421, 29003893, 29003895, 29003997, 29004030, 29004060, 29001731, 29004327, 29004345, 29004398, 29004405, 29004410, 29004419, 29004427, 29004439, 29004444, 29004384, 29004236, 29004272, 29004293, 29004308, 29004321, 29004251, 29004289, 29004080, 29004136, 29004271, 29004386, 29003389, 29004042, 29004078, 29003981, 29004083, 29004004, 29004051, 29004024, 29004068, 29004258, 29004409, 29004217, 29004417, 29004389, 29003313, 29003530, 29004198, 29004385, 29004029, 29004247, 29004266, 29004220, 29003954, 29004091, 29004124, 29004140, 29004401, 29004406, 29004438, 29004126, 29004400, 29004320, 29003988, 29004075, 29003976, 29004058, 29004113, 29004121, 29004158, 29003983, 29004094, 29004049, 29004071, 29003984, 29004005, 29004028, 29004044, 29004055, 29004065, 29004154, 29004180, 29004195, 29004420, 29004269, 29004344, 29004268, 29003607, 29004379, 29004403, 29004031, 29004246, 29004312, 29004301, 29004313, 29004255, 29004277, 29004264, 29004244, 29004245, 29002389, 29003275, 29003675, 29004115, 29004175, 29004179, 29004200, 29004207, 29004218, 29003996, 29004020, 29004019, 29003931, 29003998, 29003949, 29003966, 29004008, 29003994, 29003968, 29002280, 29003985, 29004043, 29003896, 29003986, 29004120, 29004433, 29004358

Distribution pattern

US Distribution