VITEK(R) 2 AST-P655, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobials, REF 421913 Product Usage: VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK¿ 2 utilizes growth-based biochemical patterns to determine identification. The VITEK¿ 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria.

Class I - Dangerous

🏥 Medical Devices Recalled: August 13, 2018 bioMerieux Implants & Prosthetics Nationwide

What Should You Do?

Check if you have this product:
Lot Numbers: 8050348103, 8050452403, 8050655403, 8050690403
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: bioMerieux, Inc.
Reason for Recall:: Routine internal review of Device History Records identified six VITEK(R) 2 AST card lots were manufactured with less drug (gentamicin) than required for the Gentamicin High-Level Resistance (ghlr01n) screen test due to an error when making 1500mL and 2000mL media well preparations (solutions).
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

VITEK(R) 2 AST-P655, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobials, REF 421913 Product Usage: VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK¿ 2 utilizes growth-based biochemical patterns to determine identification. The VITEK¿ 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria.

Product Codes/Lot Numbers:

Lot Numbers: 8050348103, 8050452403, 8050655403, 8050690403

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-3180-2018

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