bioMerieux, Inc. Recall 89929
Description: VITEK 2 Systems and VITEK 2 with MYLA.
bioMerieux, Inc. Recall 89929 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1059-2022 |
| Event ID | 89929 |
| Event Description | VITEK 2 Systems and VITEK 2 with MYLA. |
| Product Type | Devices |
| 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, Poland, Portugal, Russia, Serbia, Sweden, Singapore, South Africa, South Korea, Spain, Switzerland, Thailand, Turkey, and United Kingdom. |
| Quantity | 21,757 systems |
| Recall 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. |
| Device Classification | 20220518 |
| Device Code Info | VITEK 2 - Versions 8.01, 9.01, 9.02 (with or without 9MR2), 9.03 (with or without #9MR2). VITEK 2 with MYLA - Versions 4.8 and 4.9. |
| Center Classification Date | 20220511 |
| Recall Initiation Date | 20220329 |
| Recalling Firm | bioMerieux, Inc. |
| Initial Notification | Letter |
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