Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VITEK 2 Systems and VITEK 2 with MYLA. Recalled by bioMerieux, Inc. Due to Software issue where results sent to the LIS...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact bioMerieux, Inc. directly.
Affected Products
VITEK 2 Systems and VITEK 2 with MYLA.
Quantity: 21,757 systems
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 1 state: NC
About bioMerieux, Inc.
bioMerieux, Inc. has 53 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report