Recall Z-3180-2018 ยท LCD Enzyme Immunoassay, Gentamicin
bioMerieux, Inc.
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 patte
| Date | Aug 13, 2018 |
| Status | Terminated |
| Reason | 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 | 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 | 10919 cartons |
| Distribution | Worldwide Distribution US Nationwide and the countries of: Turkey, Austria, Switzerland, Czech Republic, Germany, Netherlands, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.