VITEK 2 AST Test Kits Recalled for False Colistin Resistance Results

Agency Publication Date: September 29, 2025

Summary

bioMerieux, Inc. is recalling 235,269 VITEK 2 Gram-negative AST Test Kits (reagent cards) that use the Colistin (cs02n) formulation. These automated testing cards may provide false "resistant" results when testing certain multi-drug-resistant bacteria, including Pseudomonas aeruginosa and Acinetobacter baumannii complex. This error could lead to incorrect medical decisions if healthcare providers believe a patient's infection is resistant to Colistin when it is actually sensitive.

Risk

A false resistant result may cause a doctor to avoid using Colistin, an antibiotic often used as a last resort for serious infections. This could delay effective treatment or lead to poorer clinical outcomes for patients with severe infections. No injuries or patient incidents have been reported to date.

What You Should Do

This recall affects bioMerieux VITEK 2 Gram-negative AST Test Kits (Cards) containing the Colistin formulation cs02n, used with automated laboratory instruments.
Laboratories should identify if they have any affected cards by checking the material numbers (such as 423936, 424196, and 424501) and batch numbers printed on the kit packaging. See the Affected Products section below for the full list of affected codes.
Stop using the recalled test kits immediately for Colistin susceptibility testing of Pseudomonas aeruginosa and Acinetobacter baumannii complex.
Contact bioMerieux, Inc. or your local distributor to arrange for the return, replacement, or correction of the affected cards.
Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for more information regarding medical device recalls.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: VITEK 2 AST-N412 Gram-negative AST Test Kit (20 Cards)

Model / REF:

423936

Lot Numbers:

0143139204

0143254504

0143303504

Distributed in Thailand.

Product: VITEK 2 AST-N427 Gram-negative AST Test Kit (20 Cards)

Model / REF:

424196

Lot Numbers:

0542849204

0543190104

0543266504

0542951404

0543289404

Distributed in Iberia.

Product: VITEK 2 AST-N438 Gram-negative AST Test Kit (20 Cards)

Model / REF:

424499

Lot Numbers:

0703181504

0703218104

0703273104

0703125104

Distributed in Italy.

Product: VITEK 2 AST-N439 Gram-negative AST Test Kit (20 Cards)

Model / REF:

424501

Lot Numbers:

0723192104

0723048404

0722971504

0723237504

0722860204

Distributed in Italy.

Product: VITEK 2 AST-N440 Gram-negative AST Test Kit (20 Cards)

Model / REF:

424502

Lot Numbers:

0733170404

0733317504

Distributed in Italy.

Product: VITEK 2 AST-N443 Gram-negative AST Test Kit (20 Cards)

Model / REF:

424541

Lot Numbers:

0773230404

0773247404

0772911104

Distributed in France, Spain, and Portugal.

Product: VITEK 2 AST-N444 Gram-negative AST Test Kit (20 Cards)

Model / REF:

424587

Lot Numbers:

0802553214

0802553204

Distributed in Russia.

Product: VITEK 2 AST-N447 Gram-negative AST Test Kit (20 Cards)

Model / REF:

424620

Lot Numbers:

0853198104

0853247204

Distributed in Netherlands.

Product: VITEK 2 AST-N448 Gram-negative AST Test Kit (20 Cards)

Model / REF:

424633

Lot Numbers:

0862971204

0863202504

0863296504

Distributed in Israel.

Product: VITEK 2 AST-N462 Gram-negative AST Test Kit (20 Cards)

Model / REF:

424839

Distributed in Taiwan. No specific lots listed.

Product: VITEK 2 AST-N463 Gram-negative AST Test Kit (20 Cards)

Model / REF:

424840

Distributed in Taiwan. No specific lots listed.

Product: VITEK 2 AST-N465 Gram-negative AST Test Kit (20 Cards)

Model / REF:

424842

Distributed in Taiwan. No specific lots listed.

Product: VITEK 2 AST-N475 Gram-negative AST Test Kit (20 Cards)

Model / REF:

424891

Lot Numbers:

1703184204

1703225504

Distributed in Pakistan.

Product: VITEK 2 AST-N476 Gram-negative AST Test Kit (20 Cards)

Model / REF:

424934

Lot Numbers:

1713192504

Distributed in Pakistan.

Product: VITEK 2 AST-N477 Gram-negative AST Test Kit (20 Cards)

Model / REF:

425019

Lot Numbers:

1733184104

1733205204

1733205214

Distributed in India.

Product: VITEK 2 AST-XN21 Gram-negative AST Test Kit (20 Cards)

Model / REF:

424197

Lot Numbers:

0493174204

0493310504

Distributed in Turkey.

Product: VITEK 2 AST-XN22 Gram-negative AST Test Kit (20 Cards)

Model / REF:

424199

Lot Numbers:

0552981204

0553156204

Distributed in Iberia.

Product: VITEK 2 AST-XN24 Gram-negative AST Test Kit (20 Cards)

Model / REF:

424351

Lot Numbers:

0653042204

0653217504

Distributed in Germany.

Product: VITEK 2 AST-XN25 Gram-negative AST Test Kit (20 Cards)

Model / REF:

424394

Lot Numbers:

0662155104

0662553204

Distributed in Australia.

Product: VITEK 2 AST-XN28 Gram-negative AST Test Kit (20 Cards)

Model / REF:

424586

Lot Numbers:

0793210504

0793265504

0793295504

Distributed in France.

Product: VITEK 2 AST-XN29 Gram-negative AST Test Kit (20 Cards)

Model / REF:

424604

Lot Numbers:

0822932204

0823262504

Distributed in Japan.

Product: VITEK 2 AST-XN35 Gram-negative AST Test Kit (20 Cards)

Model / REF:

424810

Lot Numbers:

1323087204

Distributed in Poland.

Product: VITEK 2 AST-XN37 Gram-negative AST Test Kit (20 Cards)

Model / REF:

424888

Lot Numbers:

1693079204

Distributed in Japan.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97269

Status: Active

Manufacturer: bioMerieux, Inc.

Sold By: Laboratory suppliers; Hospitals; Diagnostic laboratories; Authorized distributors

Manufactured In: United States

Units Affected: 235269 cards

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

This recall affects bioMerieux VITEK 2 Gram-negative AST Test Kits (Cards) containing the Colistin formulation cs02n, used with automated laboratory instruments.

Laboratories should identify if they have any affected cards by checking the material numbers (such as 423936, 424196, and 424501) and batch numbers printed on the kit packaging. See the Affected Products section below for the full list of affected codes.

Stop using the recalled test kits immediately for Colistin susceptibility testing of Pseudomonas aeruginosa and Acinetobacter baumannii complex.

Contact bioMerieux, Inc. or your local distributor to arrange for the return, replacement, or correction of the affected cards.

Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for more information regarding medical device recalls.

Affected Products

Product: VITEK 2 AST-N412 Gram-negative AST Test Kit (20 Cards)

Model / REF:

423936

Lot Numbers:

0143139204

0143254504

0143303504

Distributed in Thailand.

Product: VITEK 2 AST-N427 Gram-negative AST Test Kit (20 Cards)

Model / REF:

424196

Lot Numbers:

0542849204

0543190104

0543266504

0542951404

0543289404

Distributed in Iberia.

Product: VITEK 2 AST-N438 Gram-negative AST Test Kit (20 Cards)

Model / REF:

424499

Lot Numbers:

0703181504

0703218104

0703273104

0703125104

Distributed in Italy.

Product: VITEK 2 AST-N439 Gram-negative AST Test Kit (20 Cards)

Model / REF:

424501

Lot Numbers:

0723192104

0723048404

0722971504

0723237504

0722860204

Distributed in Italy.

Product: VITEK 2 AST-N440 Gram-negative AST Test Kit (20 Cards)

Model / REF:

424502

Lot Numbers:

0733170404

0733317504

Distributed in Italy.

Product: VITEK 2 AST-N443 Gram-negative AST Test Kit (20 Cards)

Model / REF:

424541

Lot Numbers:

0773230404

0773247404

0772911104

Distributed in France, Spain, and Portugal.

Product: VITEK 2 AST-N444 Gram-negative AST Test Kit (20 Cards)

Model / REF:

424587

Lot Numbers:

0802553214

0802553204

Distributed in Russia.

Product: VITEK 2 AST-N447 Gram-negative AST Test Kit (20 Cards)

Model / REF:

424620

Lot Numbers:

0853198104

0853247204

Distributed in Netherlands.

Product: VITEK 2 AST-N448 Gram-negative AST Test Kit (20 Cards)

Model / REF:

424633

Lot Numbers:

0862971204

0863202504

0863296504

Distributed in Israel.

Product: VITEK 2 AST-N462 Gram-negative AST Test Kit (20 Cards)

Model / REF:

424839

Distributed in Taiwan. No specific lots listed.

Product: VITEK 2 AST-N463 Gram-negative AST Test Kit (20 Cards)

Model / REF:

424840

Distributed in Taiwan. No specific lots listed.

Product: VITEK 2 AST-N465 Gram-negative AST Test Kit (20 Cards)

Model / REF:

424842

Distributed in Taiwan. No specific lots listed.

Product: VITEK 2 AST-N475 Gram-negative AST Test Kit (20 Cards)

Model / REF:

424891

Lot Numbers:

1703184204

1703225504

Distributed in Pakistan.

Product: VITEK 2 AST-N476 Gram-negative AST Test Kit (20 Cards)

Model / REF:

424934

Lot Numbers:

1713192504

Distributed in Pakistan.

Product: VITEK 2 AST-N477 Gram-negative AST Test Kit (20 Cards)

Model / REF:

425019

Lot Numbers:

1733184104

1733205204

1733205214

Distributed in India.

Product: VITEK 2 AST-XN21 Gram-negative AST Test Kit (20 Cards)

Model / REF:

424197

Lot Numbers:

0493174204

0493310504

Distributed in Turkey.

Product: VITEK 2 AST-XN22 Gram-negative AST Test Kit (20 Cards)

Model / REF:

424199

Lot Numbers:

0552981204

0553156204

Distributed in Iberia.

Product: VITEK 2 AST-XN24 Gram-negative AST Test Kit (20 Cards)

Model / REF:

424351

Lot Numbers:

0653042204

0653217504

Distributed in Germany.

Product: VITEK 2 AST-XN25 Gram-negative AST Test Kit (20 Cards)

Model / REF:

424394

Lot Numbers:

0662155104

0662553204

Distributed in Australia.

Product: VITEK 2 AST-XN28 Gram-negative AST Test Kit (20 Cards)

Model / REF:

424586

Lot Numbers:

0793210504

0793265504

0793295504

Distributed in France.

Product: VITEK 2 AST-XN29 Gram-negative AST Test Kit (20 Cards)

Model / REF:

424604

Lot Numbers:

0822932204

0823262504

Distributed in Japan.

Product: VITEK 2 AST-XN35 Gram-negative AST Test Kit (20 Cards)

Model / REF:

424810

Lot Numbers:

1323087204

Distributed in Poland.

Product: VITEK 2 AST-XN37 Gram-negative AST Test Kit (20 Cards)

Model / REF:

424888

Lot Numbers:

1693079204

Distributed in Japan.