bioMerieux, Inc.: Medical Device Recall in 2018 - (Recall #: Z-3180-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product 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 Classification:

Class II

Date Initiated: August 13, 2018

Date Posted: September 26, 2018

Recall Number: Z-3180-2018

Event ID: 80860

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).

Status: Terminated

Product Quantity: 10919 cartons

Code Information:

Lot Numbers: 8050348103, 8050452403, 8050655403, 8050690403

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated