# FDA recall Z-0962-2019

> **Organon Teknika Inc** · Class II · device recall initiated 2019-01-11.

## 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

## Distribution

Worldwide distribution.

## Key facts

- **Recall number:** Z-0962-2019
- **Recalling firm:** Organon Teknika Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-01-11
- **Report date:** 2019-03-06
- **Termination date:** 2020-11-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Durham, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0962-2019

## Citation

> AI Analytics. FDA recall Z-0962-2019. Retrieved 2026-07-17 from https://api.ai-analytics.org/recall/Z-0962-2019. Source: US FDA. Licensed CC0.

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