Z-0962-2019Class II

Vitek 2 reagent cards: a) GN ID, REF 21341, b) GP ID, REF 21342, c) ANC ID, REF 21347, d) AST-GNOR, REF...

Name: Z-0962-2019 Vitek 2 reagent cards: a) GN ID, REF 21341, b) GP ID, REF 21342, c) ANC ID, REF 21347, d) AST-GNOR, REF...
Creator: Organon Teknika Inc
Published: 2019-01-11
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2019-01-11 / Terminated / root cause: manufacturing process

FDA source

Organon Teknika Inc began a recall of 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... on 2019-01-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0962-2019
Classification: Class II
Status: Terminated
Initiated: 2019-01-11
Posted: 2019-02-27
Terminated: 2020-11-06
Recalling firm: bioMerieux, Inc.
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,
Product code: LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
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
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The recall was issued to bioMrieux subsidiaries and distributors via email notification on Friday, January 11th, 2019. Impacted customers were notified via correction notice (customer letter) issued on 01/19/2019 from each associated subsidiary/distributor onto local letterhead. The letter directed the user to perform a "tug test" to determine if the product is defective. Defective units were to be discarded and a credit issued.
Quantity in commerce: 129,321 cartons
Distribution: Worldwide distribution.
Product codes and lots: a) GN ID, REF 21341: Lot Numbers: 2410602403, 2410624103, 2410632203, 2410635203, 2410636203, 2410637203 b) GP ID, REF 21342, Lot Numbers: 2420806103, 2420818403, 2420822203 c) ANC ID, REF 21347, Lot Numbers: 2440811203 d) AST-GNOR, REF 22000, Lot Numbers: 1010810203 e) AST-GP67, REF 22226, Lot Numbers: 1320808103, 1320816203, 1320820403 f) AST-P612, REF 22359, Lot Numbers: 4920814403 g) AST-XN01, REF 410025, Lot Numbers: 3130813203 h) AST-N222, REF 413083, Lot Numbers: 6220813203 i) AST-N223, REF 413110, Lot Numbers: 6230811103 j) AST-N226, REF 413143, Lot Numbers: 6260813203 k) AST-N248, REF 413397, Lot Numbers: 6480817203 l) ASR-GN67, REF 413399, Lot Numbers: 5870818203 m) AST-GN69, REF 413400, Lot Numbers: 5890803203, 5890806203, 5890820203 n) AST-GN73, REF 413404, Lot Numbers: 5930821203 o) AST-GN79, REF 413436, Lot Numbers: 5990817203 p) AST-GN82, REF 413439, Lot Numbers: 6720813203 q) AST-N261, REF 413753, Lot Numbers: 6610807203 r) AST-XN06, REF 413944, Lot Numbers: 1490809103 s) AST-N275, REF 414313, Lot numbers: 6950810203 t) AST-GP75, REF 415670, Lot Numbers: 2750809103, 2750823203 u) AST-N300, REF 416241, Lot Numbers: 7200810203 v) AST-N308, REF 413913, Lot Numbers: 7280810203 w) AST-N314, REF 417027, Lot Numbers: 7540810203 x) AST-N318, REF 417952, Lot Numbers: 7580813203 y) AST-P643, REF 418671, Lot Numbers: 7430809203 z) AST-YS08, REF 420739, Lot Numbers: 2880809203, 2880812203 aa) AST-N348, REF 420856, Lot Numbers: 7880811203 bb) AST-ST02, REF 420915, Lot Numbers: 5410812203 cc) AST-ST03, REF 421040, Lot Numbers: 5420809203, 5420812203 dd) AST-N355, REF 421351, Lot Numbers: 7950805203 ee) AST-P654, REF 421912, Lot Numbers: 8040822203 ff) AST-P655, REF 421913, Lot Numbers: 8050823203 gg) AST-N371, REF 422024, Lot Numbers: 210805204 hh) AST-N372, REF 422241, Lot Numbers: 220810404 ii) AST-N379, REF 423052, Lot Numbers: 290815204

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0962-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0962-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-27

Product code LON

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)