Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
BioMerieux VIDAS System in combination with Quality Control VIDAS* (QCV*) Recalled by bioMerieux, Inc. Due to Increase of events affecting performance regarding pump clogging...
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
BioMerieux VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality Control VIDAS (QCV) is an automated test for use on the VIDAS¿ system to detect abnormal operation of the VIDAS and mini VIDAS instrument pipette mechanisms and optical systems. Specifically the mini VIDAS system is an immunodiagnostic system intended to be used by trained and qualified laboratory professionals, for In vitro Diagnostic (IVD) purpose, veterinary and industrial applications. The mini VIDAS¿ system is intended to execute an immunoassay protocol and to release results according to the package insert of the VIDAS¿ assay kits.
Quantity: 1,866 units
Why Was This Recalled?
Increase of events affecting performance regarding pump clogging and displacement of the color-coded SPR label (DOT). These performance issues could contribute to erroneous results for any assay performed on the VIDAS¿ and mini VIDAS¿ system due to a decrease of pipetted volume.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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