Recall Z-1059-2022 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
bioMerieux, Inc.
VITEK 2 Systems and VITEK 2 with MYLA.
| Date | Mar 29, 2022 |
| Status | Open, Classified |
| Reason | Software issue where results sent to the LIS via HL7 format for antibiotic screen tests and synergy tests do not include the user-corrected or AES-corrected interpretation. This can potentially lead to incorrect final screen/synergy test results at the LIS. |
| Root cause | Software design |
| Action | The recalling firm issued Field Safety Corrective Action (FSCA) #5615 dated 29-MAR-2022 to the impacted subsidiaries and distributors. It explained the affected product, issue, and informed the recipient the resolution for the issue has been implemented in VITEK 2 Systems software maintenance release 9MR3 launched 15-MAR-2022 and available in VILINK. It was recommended to convert HL7 users to VITEK 2 Software Version 9.03 and apply the software patch 9MR3 as quickly as possible. Workarounds were provided pending installation of 9MR3 to ensure there are no adverse impact to patients. The FS |
| Quantity | 21,757 systems |
| Distribution | U.S. distribution of the FSCA to NC. OUS distribution of the FSCA to subsidiaries in Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Egypt, Finland, France, Germany, Greece, Hungary, India, Italy, Japan, Mexico, Netherlands, Norway, Philippines, Polan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.