Recall Z-1059-2022— bioMerieux, Inc.
Class II · Ongoing
Class II FDA medical device recall by bioMerieux, Inc., initiated 2022-03-29. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- bioMerieux, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-03-29
- Firm location
- Durham, NC, United States
Product description
VITEK 2 Systems and VITEK 2 with MYLA.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.