bioMerieux, Inc.: 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).

Agency Publication Date: September 15, 2018

Affected Products

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) r

Lot Numbers: 7400410103, 7400697403

Lot Numbers:

Numbers

Product: 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) r

Lot Numbers: 8050348103, 8050452403, 8050655403, 8050690403

Lot Numbers:

Numbers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80860

Status: Resolved

Manufacturer: bioMerieux, Inc.

Manufactured In: United States

Units Affected: 2 products (2538 cartons; 10919 cartons)

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Sources: FDA iRES · Raw API Response

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Affected Products

Lot Numbers: 7400410103, 7400697403

Lot Numbers:

Numbers

Lot Numbers: 8050348103, 8050452403, 8050655403, 8050690403

Lot Numbers:

Numbers