Reported Mar 6, 2019 · Terminated
Vitek 2 reagent cards
Organon Teknika Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Organon Teknika Inc · 100 Rodolphe St Bldg 1300 · Durham, NC · 27712-9402
Is this the product you have?
Vitek 2 reagent cards
31 of 31 products
| Model / number | Product as published |
|---|---|
AST-GP67 | REF 22000, e) |
AST-P612 | REF 22226, f) |
AST-XN01 | REF 22359, g) |
AST-N222 | REF 410025, h) |
AST-N223 | REF 413083, i) |
AST-N226 | REF 413110, j) |
AST-N248 | REF 413143, k) |
ASR-GN67 | REF 413397, l) |
AST-GN69 | REF 413399, m) |
AST-GN73 | REF 413400, n) |
AST-GN79 | REF 413404, o) |
AST-GN82 | REF 413436, p) |
AST-N261 | REF 413439, q) |
AST-XN06 | REF 413753, r) |
AST-N275 | REF 413944, s) |
AST-GP75 | REF 414313, t) |
AST-N300 | REF 415670, u) |
AST-N308 | REF 416241, v) |
AST-N314 | REF 413913, w) |
AST-N318 | REF 417027, x) |
- Lot codes and dates
26 of 26 products
Products covered by this recall Model / number Product as published 21341GN ID, : Lot Numbers: 2410602403, 2410624103, 2410632203, 2410635203, 2410636203, 2410637203 21342GP ID, , Lot Numbers: 2420806103, 2420818403, 2420822203 21347ANC ID, , Lot Numbers: 2440811203 22000AST-GNOR, , Lot Numbers: 1010810203 22226AST-GP67, , Lot Numbers: 1320808103, 1320816203, 1320820403 22359AST-P612, , Lot Numbers: 4920814403 410025AST-XN01, , Lot Numbers: 3130813203 413083AST-N222, , Lot Numbers: 6220813203 413110AST-N223, , Lot Numbers: 6230811103 413143AST-N226, , Lot Numbers: 6260813203 413397AST-N248, , Lot Numbers: 6480817203 413399ASR-GN67, , Lot Numbers: 5870818203 413400AST-GN69, , Lot Numbers: 5890803203, 5890806203, 5890820203 413404AST-GN73, , Lot Numbers: 5930821203 413436AST-GN79, , Lot Numbers: 5990817203 413439AST-GN82, , Lot Numbers: 6720813203 413753AST-N261, , Lot Numbers: 6610807203 413944AST-XN06, , Lot Numbers: 1490809103 414313AST-N275, , Lot numbers: 6950810203 415670AST-GP75, , Lot Numbers: 2750809103, 2750823203 - Amount recalled
- 129,321 cartons
Why it was recalled
This notice has been initiated due to potential for compromised test card Top Seal Integrity which could: - yield false resistance for antibiotics on the AST panel - cause a false negative ESBL Test - result in a false positive urea (URE) reaction on ID cards
This product could cause temporary or reversible health problems — stop using it.
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