Recall Z-0639-2019 · LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
bioMerieux, Inc.
VITEK 2 Systems Software Version 9.01 Update Kit.
| Date | Nov 13, 2018 |
| Status | Terminated |
| Reason | The VITEK 2 Systems Software Version 9.01 software may display incorrect organism identification information as well as the associated Antimicrobial Susceptibility Testing (AST) results when using the VITEK 2 FLEXPREP" feature. |
| Root cause | Software design |
| Action | bioMerieux notified customers of the recall on about 11/13/2018 via "URGENT PRODUCT CORRECTION NOTICE." Instructions included taking the following actions: 1) Confirm the letter has been distributed to, and reviewed by, all appropriate personnel; 2) If appropriate in accordance with consignee's laboratory's Standard Operating Procedures, perform retrospective review of any patient results potentially impacted in relation to the described VITEK FLEXPREP anomaly; 3) Store this letter with the bioMrieux, Inc. VITEK 2 instrument documentation; 4) Complete and return the Acknowledgement Form in A |
| Quantity | five (5) VITEK¿ 2 Systems Software version 9.01 |
| Distribution | Nationwide distribution to CO, IL, MO, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050002 | VITEK 2 COMPACT bioMerieux, Inc., Feb 17, 2005 |