CLASS II Device recall · Reported 6 Mar 2019 · FDA Enforcement Report
Vitek 2 reagent cards: a) GN ID recalled by Organon Teknika
Organon Teknika is recalling Vitek 2 reagent cards: a) GN ID. The recall was initiated on 11 Jan 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0962-2019
- FDA event ID
- 81934
- Recalling firm
- Organon Teknika, Durham, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Jan 2019
- FDA classified
- 27 Feb 2019
- Reported
- 6 Mar 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Test Kits & Diagnostics
Timeline
| 11 Jan 2019 | Recall initiated by company | |
| 27 Feb 2019 | Classified by FDA | +47 days |
| 6 Mar 2019 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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,
Where it was distributed
Worldwide distribution.
Questions about this recall
Why was it 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
Which lots are affected?
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
Where was it sold?
Worldwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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