Organon Teknika Inc: 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

Recall number

Z-0962-2019

Recalling firm

Organon Teknika 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,

Status

Terminated

Initiated

2019-01-11

Posted

not on file

Terminated

2020-11-06

Reason

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

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

129,321 cartons

Distribution

Worldwide distribution.

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

not on file

Product code

LON

Firm FEI

1950204

Firm city

Durham

Firm state

NC

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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