Recall Z-3075-2017 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Biomerieux Inc
VITEK 2 Compact 15, REF numbers: 27415 and 27415R software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testing (AST) of bacteria and yeast.
| Date | Jul 12, 2017 |
| Status | Terminated |
| Reason | Customers have reported that some VITEK 2 cards are staying in preliminary status, not finalizing after ejection from the instrument, and not allowing cards in subsequent carousel slots to be processed. The issue was reported to occur on VITEK 2 Compact 15 and Compact 30 systems following a system software update to version 8.01. |
| Root cause | Other |
| Action | Consignees (Subsidiaries) of bioMrieux, impacted by the identified issue, were notified of the FSCA and corrective action (FSCA notification) electronically on 07/12/2017. The direct consignees (subsidiaries and distributors) have until 08/12/2017 to notify their respective impacted users. The directions to the user are as follows: Please implement the following actions at this time: " Confirm this letter has been distributed to, and reviewed by, all appropriate personnel within your organization. " Refrain from performing the VITEK 2 Systems Software 8.01 update. o A solution has been i |
| Quantity | 1866 units |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050002 | VITEK 2 COMPACT bioMerieux, Inc., Feb 17, 2005 |