bioMerieux, Inc.: VITEK 2 AST Veterinary Test Kits Recalled for False Negative MRSA Results

Agency Publication Date: May 23, 2019

Summary

bioMerieux is recalling approximately 12,152 units of various VITEK 2 AST Veterinary Test Kits used for identifying bacterial infections in animals. These kits are being recalled because customer reports indicate an increase in the rate of undetected Methicillin-resistant Staphylococcus aureus (MRSA). The recall includes GP69, GP76, GP79, GP80, and GP81 test cards used in veterinary diagnostic settings. Healthcare providers and veterinary labs should immediately check their inventory for these specific cards which include the antibiotics Oxacillin and Cefotoxin.

Risk

The test kits may fail to detect MRSA, leading to an incorrect diagnosis where a resistant infection is treated as a standard infection. This can result in the use of ineffective antibiotics, potentially causing treatment failure or the worsening of infections in animals.

What You Should Do

Check your laboratory inventory for bioMerieux VITEK 2 AST-GP69, AST-GP76, AST-GP79, AST-GP80, or AST-GP81 Veterinary Test Kits.
Identify affected products by looking for 'Ref' numbers 22304, 418424, 421825, 421826, or 421827 and UDI codes starting with 03573026.
Note that this recall affects all lots of Gram Positive (GP) cards that contain Oxacillin (OX) and Cefotoxin (OXSF).
Immediately stop using the affected test cards for MRSA detection in veterinary samples.
Contact your healthcare provider or the manufacturer, bioMerieux, Inc., at their Durham, North Carolina facility for further instructions regarding replacement products or potential refunds.
For additional questions, contact the FDA Consumer Complaint Coordinator at 1-888-463-6332.

Your Remedy Options

Other Action

Manufacturer Notification

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: bioMerieux VITEK 2 AST-GP69 Test Kit (Veterinary)

Model:

Ref: #22304

UPC Codes:

03573026311636

Lot Numbers:

all lots of cards with Oxacillin and Cefotoxin

Product: bioMerieux VITEK 2 AST-GP76 Test Kit (Veterinary)

Model:

Ref: #418424

UPC Codes:

03573026470036

Lot Numbers:

all lots of cards with Oxacillin and Cefotoxin

Product: bioMerieux VITEK 2 AST-GP79 Test Kit (Veterinary)

Model:

Ref: #421825

UPC Codes:

03573026563745

Lot Numbers:

all lots of cards with Oxacillin and Cefotoxin

Product: bioMerieux VITEK 2 AST-GP80 Test Kit (Veterinary)

Model:

Ref: #421826

UPC Codes:

03573026563752

Lot Numbers:

all lots of cards with Oxacillin and Cefotoxin

Product: bioMerieux VITEK 2 AST-GP81 Test Kit (Veterinary)

Model:

Ref: #421827

UPC Codes:

03573026565763

Lot Numbers:

all lots of cards with Oxacillin and Cefotoxin

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80760

Status: Active

Manufacturer: bioMerieux, Inc.

Sold By: Authorized veterinary diagnostic distributors

Manufactured In: United States

Units Affected: 5 products (299 cartons (20 individual kits in each carton); 11,121 cartons (20 individual kits in each carton); 6 cartons (20 individual kits in each carton); 6 cartons (20 individual kits in each carton); 720 cartons (20 individual kits in each carton))

Distributed To: Alabama, Arkansas, California, Colorado, Florida, Georgia, Illinois, Kentucky, Massachusetts, Missouri, New York, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Washington

Agency Last Updated: June 6, 2019

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

Summary

What You Should Do

Check your laboratory inventory for bioMerieux VITEK 2 AST-GP69, AST-GP76, AST-GP79, AST-GP80, or AST-GP81 Veterinary Test Kits.

Identify affected products by looking for 'Ref' numbers 22304, 418424, 421825, 421826, or 421827 and UDI codes starting with 03573026.

Note that this recall affects all lots of Gram Positive (GP) cards that contain Oxacillin (OX) and Cefotoxin (OXSF).

Immediately stop using the affected test cards for MRSA detection in veterinary samples.

Contact your healthcare provider or the manufacturer, bioMerieux, Inc., at their Durham, North Carolina facility for further instructions regarding replacement products or potential refunds.

For additional questions, contact the FDA Consumer Complaint Coordinator at 1-888-463-6332.

Affected Products

Product: bioMerieux VITEK 2 AST-GP69 Test Kit (Veterinary)

Model:

Ref: #22304

UPC Codes:

03573026311636

Lot Numbers:

all lots of cards with Oxacillin and Cefotoxin

Product: bioMerieux VITEK 2 AST-GP76 Test Kit (Veterinary)

Model:

Ref: #418424

UPC Codes:

03573026470036

Lot Numbers:

all lots of cards with Oxacillin and Cefotoxin

Product: bioMerieux VITEK 2 AST-GP79 Test Kit (Veterinary)

Model:

Ref: #421825

UPC Codes:

03573026563745

Lot Numbers:

all lots of cards with Oxacillin and Cefotoxin

Product: bioMerieux VITEK 2 AST-GP80 Test Kit (Veterinary)

Model:

Ref: #421826

UPC Codes:

03573026563752

Lot Numbers:

all lots of cards with Oxacillin and Cefotoxin

Product: bioMerieux VITEK 2 AST-GP81 Test Kit (Veterinary)

Model:

Ref: #421827

UPC Codes:

03573026565763

Lot Numbers:

all lots of cards with Oxacillin and Cefotoxin

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80760

Status: Active

Manufacturer: bioMerieux, Inc.

Sold By: Authorized veterinary diagnostic distributors

Manufactured In: United States

Agency Last Updated: June 6, 2019