—#166752

Product

VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobials, REF 418579 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.

FDA product code: LCD — Enzyme Immunoassay, Gentamicin
Device class: Class 2
Medical specialty: Clinical Toxicology
Affected lot / code info: Lot Numbers: 7400410103, 7400697403

Why it was recalled

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).

Root cause (FDA determination)

Process control

Action the firm took

The firm initiated the recall by email on 08/13/2018. The firm requested the consignee discard the impacted product and contact the local bioMerieux representative for credit.

Recalling firm

Firm: bioMerieux, Inc.
Address: 100 Rodolphe St, Durham, North Carolina 27712-9402

Distribution

Distribution pattern: Worldwide Distribution US Nationwide and the countries of: Turkey, Austria, Switzerland, Czech Republic, Germany, Netherlands,

Timeline

Recall initiated: 2018-08-13
Terminated: 2020-11-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #166752. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.