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Z-3179-2018 Class II Terminated

Recalled by bioMerieux, Inc. — Durham, NC

FDA device recall Z-3179-2018 was initiated by bioMerieux, Inc. on Aug 13, 2018 and is designated Class II. 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)… The recall status is terminated (terminated Nov 2, 2020). Affected quantity: 2538 cartons.

Recall Details

Product Type: Devices
Report Date: Sep 26, 2018
Initiation Date: Aug 13, 2018
Termination Date: Nov 2, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2538 cartons

Product Description

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.

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).

Distribution Pattern

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

Code Information

Lot Numbers: 7400410103, 7400697403

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-3179-2018
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 24, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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