# FDA recall Z-1236-2026

> **Biomerieux Inc** · Class II · device recall initiated 2026-01-05.

## Product

VITEK 2 Gram-negative Susceptibility Cards Containing o	Polymyxin B (pb02n) o	Ceftazidime/avibactam (cza02n) o	Meropenem/Vaborbactam (mev01n) o	Imipenem (ipm05n) o	Imipenem/Relebactam (ipr01n);  CARD NAME/ PRODUCT REFERENCE:  AST-N399  	423701  AST-N402  	423644  AST-N403  	423645  AST-N404  	423664  AST-N405  	423864  AST-N406  	423869  AST-N407  	423870  AST-N409  	423925  AST-N412  	423936  AST-N413  	423928  AST-N414  	423933  AST-N415  	423934  AST-N416  	423935  AST-N417  	423880  AST-N419  	423948  AST-N421  	424055  AST-N428  	424320  AST-N429  	424321  AST-N430  	424322  AST-N433  	424389  AST-N439  	424501  AST-N440  	424502  AST-N443  	424541  AST-N444  	424587  AST-N467  	424857  AST-N476  	424934  AST-N478  	425052  AST-N480 	425084  AST-N481  	425085  AST-N485 	425182  AST-N496 	425265  AST-N800  	423310  AST-N802  	423706  AST-N804  	424634  AST-N808  	424711  AST-N810 	424712  AST-N811  	424713  AST-N813  	424722  AST-N815  	425054  AST-XN09  	423425  AST-XN15  	423829 

## Reason for recall

Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with the identified antibiotic formulations. Issue may lead to QC failure or false resistant results.

## Distribution

Worldwide - US Nationwide distribution.

## Key facts

- **Recall number:** Z-1236-2026
- **Recalling firm:** Biomerieux Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-01-05
- **Report date:** 2026-02-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hazelwood, MO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1236-2026

## Citation

> AI Analytics. FDA recall Z-1236-2026. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-1236-2026. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*