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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81934

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
January 11, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Organon Teknika Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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,

Z-0962-2019
Recall number
Z-0962-2019
Initiated
January 11, 2019
Classification
Class II
Status
Terminated
Recalling firm
Organon Teknika Inc
Quantity
129,321 cartons

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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

Code information

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

Distribution pattern

Worldwide distribution.