Z-3180-2018Class II

VITEK(R) 2 AST-P655, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae...

Name: Z-3180-2018 VITEK(R) 2 AST-P655, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae...
Creator: bioMerieux, Inc.
Published: 2018-08-13
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2018-08-13 / Terminated / root cause: manufacturing process

FDA source

bioMerieux, Inc. began a recall of VITEK(R) 2 AST-P655, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobials, REF 421913 Product... on 2018-08-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3180-2018
Classification: Class II
Status: Terminated
Initiated: 2018-08-13
Posted: 2018-09-15
Terminated: 2020-11-02
Recalling firm: bioMerieux, Inc.
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) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria.
Product code: LCD Enzyme Immunoassay, Gentamicin
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).
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 10919 cartons
Distribution: Worldwide Distribution US Nationwide and the countries of: Turkey, Austria, Switzerland, Czech Republic, Germany, Netherlands,
Product codes and lots: Lot Numbers: 8050348103, 8050452403, 8050655403, 8050690403

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3180-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3179-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-14
Z-3180-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-14

Product code LCD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)