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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83410

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

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Event summary

Timeline bucket
February 15, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Alere San Diego, Inc.

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

Alere Cholestech LDX Analyzer, model # 14-874 containing power supplies with the identifying codes of 1837d and 1843d - Product Usage: The Alere Cholestech LDX System is a small, portable analyzer and test cassette system. The System is for in vitro diagnostic use only. The Lipid Profile GLU Cassette is for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, triglycerides and glucose in whole blood. A TC/HDL (total cholesterol/HDL cholesterol) ratio and estimated values for LDL (low-density lipoprotein) and non-HDL cholesterol are calculated by the Alere Cholestech LDX¿ Analyzer.

Z-2475-2019
Recall number
Z-2475-2019
Initiated
February 15, 2019
Classification
Class II
Status
Terminated
Recalling firm
Alere San Diego, Inc.
Quantity
186 analyzer kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The polarity of the output of power supply was reversed. Due to polarity of the output of power supplies being reversed, it renders the power supplies nonfunctional and the analyzer inoperable.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The polarity of the output of power supply was reversed. Due to polarity of the output of power supplies being reversed, it renders the power supplies nonfunctional and the analyzer inoperable.

Code information

Lot/Unit Codes: Lot codes of Meter Kits: 418197, 418198, 418199, 418252, & 418253 Lot codes of Power Supplies: 724599, 724604, & 725914 Serial Numbers: AA184455, AA184344, AA184328, AA184388, AA184304, AA184349, AA184396, AA184339, AA184421, AA184280, AA184435, AA184427, AA184395, AA183401, AA184394, AA184710, AA184345, AA184039, AA184463, AA184609, AA184383, AA184415, AA184094, AA184070, AA184412, AA183861, AA184278, AA184283, AA184711, AA184392, AA184343, AA184368, AA184708, AA184350, AA184674, AA184378, AA184433, AA184366, AA184365, AA184354, AA184369, AA184067, AA184353, AA184664, AA184279, AA184355, AA184270, AA184285, AA184017, AA184272, AA184340, AA184346, AA184347, AA184336, AA184342, AA184269, AA184376, AA184949, AA184386, AA184351, AA184341, AA184413, AA184298, AA183707, AA184595, AA184364, AA184287, AA184618, AA184971, AA184334, AA184845, AA184267, AA184296, AA184333, AA184608, AA184651, AA184319, AA184348, AA184317, AA184699, AA184430, AA184432, AA184363, AA184030, AA184338, AA184371, AA184375, AA184393, AA184306, AA184447, AA183418, AA184323, AA184401, AA184438, AA184594, AA184281, AA184461, AA184312, AA184321, AA184288, AA184357, AA184380, AA184617, AA184352, AA184273, AA184303, AA184424, AA184290, AA184300, AA184916, AA184965, AA184963, AA184980, AA184964, AA184955, AA185069, AA185009, AA184904, AA184993, AA184973, AA184991, AA184995, AA184900, AA185046, AA184951, AA185927, AA184468, AA185050, AA184967, AA184853, AA184877, AA184830, AA184961, AA184794, AA184930, AA184459, AA184887, AA184869, AA185020, AA184785, AA184985, AA184901, AA184979, AA184990, AA184865, AA184988, AA184872, AA184952, AA184946, AA184924, AA182949, AA184918, AA184928, AA184886, AA184957, AA184974, AA184862, AA185022, AA184657, AA184880, AA185021, AA184922, AA184875, AA185013, AA184943, AA184873, AA184989, AA184742, AA184876, AA184301, AA184367, AA184370, AA184359, AA184434, AA184615, AA185004, AA184678, AA184329, AA184377, AA184326, AA184284, AA184384, AA184795, AA184297, AA183549, AA184318

Distribution pattern

US Nationwide distribution in the states of AK, A, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NY< OH, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI. No OUS consignees