Vitek 2 reagent cards: a) GN ID — Class II medical device recall Z-0962-2019
Terminated recall by Organon Teknika Inc, reported 2019-03-06. This notice has been initiated due to potential for compromised test card Top Seal Integrity which could: - yi
| Recall number | Z-0962-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Organon Teknika Inc, Durham, NC, United States |
| Recall initiated | 2019-01-11 |
| Classified | 2019-02-27 |
| Reported by FDA | 2019-03-06 |
| Terminated | 2020-11-06 |
| Quantity | 129,321 cartons |
| Reason classes | packaging |
| Lot numbers | 1010810203, 1320808103, 1320816203, 1320820403, 1490809103, 210805204, 220810404, 2410602403, 2410624103, 2410632203, 2410635203, 2410636203, 2410637203, 2420806103, 2420818403, 2420822203, 2440811203, 2750809103, 2750823203, 2880809203, 2880812203, 290815204, 3130813203, 4920814403, 5410812203, 5420809203, 5420812203, 5870818203, 5890803203, 5890806203, 5890820203, 5930821203, 5990817203, 6220813203, 6230811103, 6260813203, 6480817203, 6610807203, 6720813203, 6950810203 and 9 more |
| Model numbers | 21341, 21342, 21347, 22000, 22226, 22359, 410025, 413083, 413110, 413143, 413397, 413399, 413400, 413404, 413436, 413439, 413753, 413913, 413944, 414313, 415670, 416241, 417027, 417952, 418671 and 10 more |
Product
Vitek 2 reagent cards: a) GN ID, REF 21341, b) GP ID, REF 21342, c) ANC ID, REF 21347, d) AST-GNOR, REF 22000, e) AST-GP67, REF 22226, f) AST-P612, REF 22359, g) AST-XN01, REF 410025, h) AST-N222, REF 413083, i) AST-N223, REF 413110, j) AST-N226, REF 413143, k) AST-N248, REF 413397, l) ASR-GN67, REF 413399, m) AST-GN69, REF 413400, n) AST-GN73, REF 413404, o) AST-GN79, REF 413436, p) AST-GN82, REF 413439, q) AST-N261, REF 413753, r) AST-XN06, REF 413944, s) AST-N275, REF 414313, t) AST-GP75, REF 415670, u) AST-N300, REF 416241, v) AST-N308, REF 413913, w) AST-N314, REF 417027, x) AST-N318, REF 417952, y) AST-P643, REF 418671, z) AST-YS08, REF 420739, aa) AST-N348, REF 420856, bb) AST-ST02, REF 420915, cc) AST-ST03, REF 421040, dd) AST-N355, REF 421351, ee) AST-P654, REF 421912, ff) AST-P655, REF 421913, gg) AST-N371, REF 422024, hh) AST-N372, REF 422241, ii) AST-N379, REF 423052,
Reason for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0962-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.