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.

Class I - Dangerous

🏥 Medical Devices Recalled: January 4, 2018 bioMerieux Diagnostic Equipment Nationwide

What Should You Do?

Check if you have this product:
Description, Reference No. (UDI No.): VIDAS ANALYSER 110/220V, 93296 (03573026133573); VIDAS ANALYSER 220V, 93297 (03573026133580); VIDAS ANALYSEUR, 99011 (03573026109257); VIDAS ANALYSER EU, 99444 (03573026114060); VIDAS ANALYSER US, 99445 (03573026114084); VIDAS ANALYSER, 99735 (03573026140427); VIDAS ANALYSER US, W2205 (03573026029678); VIDAS ANALYSER, 410417 (03573026351663); Quality Control VIDAS¿ (QCV), 30706 (03573026121631); VIDAS ANALYSER EU, W3205 (03573026030292); VIDAS INDUSTRY US, 421002 (03573026553319)
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: bioMerieux, Inc.
Reason for Recall:: 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.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

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.

Product Codes/Lot Numbers:

Description, Reference No. (UDI No.): VIDAS ANALYSER 110/220V, 93296 (03573026133573); VIDAS ANALYSER 220V, 93297 (03573026133580); VIDAS ANALYSEUR, 99011 (03573026109257); VIDAS ANALYSER EU, 99444 (03573026114060); VIDAS ANALYSER US, 99445 (03573026114084); VIDAS ANALYSER, 99735 (03573026140427); VIDAS ANALYSER US, W2205 (03573026029678); VIDAS ANALYSER, 410417 (03573026351663); Quality Control VIDAS¿ (QCV), 30706 (03573026121631); VIDAS ANALYSER EU, W3205 (03573026030292); VIDAS INDUSTRY US, 421002 (03573026553319)

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2429-2018

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