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Sources: EU EUDAMED, US FDA
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Status: Terminated
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BioMerieux mini 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.
FDA Recall
Terminated
·bioMerieux, Inc.·Product code JJE·January 4, 2018
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.
FDA Recall
Terminated
·bioMerieux, Inc.·Product code JJE·January 4, 2018
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.
FDA Enforcement
Class II
·Terminated·bioMerieux, Inc.·July 18, 2018
BioMerieux mini 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.
FDA Enforcement
Class II
·Terminated·bioMerieux, Inc.·July 18, 2018
Psi Bands acupressure/acustimulation wrist bands in the following colors: Racer Black (UPC 859570001036), Daisy Chain (UPC 859570001029), Color Play (UPC 859570001043) and Cherry Blossom (UPC 859570001012).
FDA Recall
Terminated
·Psi Health Solutions·Product code MVV·April 26, 2007