Recall archive / FDA device enforcement
VITEK 2 Systems and VITEK 2 with MYLA. — FDA record Z-1059-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 29, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- VITEK 2 Systems and VITEK 2 with MYLA.
- 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.
- Classification
- Class II
- Recalling firm
- bioMerieux, Inc.
- Quantity
- 21,757 systems
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1059-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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. |
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- May 18, 2022
- Recall initiation date
- Mar 29, 2022
- Center classification date
- May 11, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.