Reported Jul 18, 2018 · Terminated
BioMerieux mini VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality Control VIDAS…
bioMerieux, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: bioMerieux, Inc. · 100 Rodolphe St · Durham, NC · 27712-9402
Is this the product you have?
- BioMerieux mini VIDAS System in combination with Quality Control VIDAS* (QCV*)
- Product Usagethe 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
- Lot codes and dates
9 of 9 products
Products covered by this recall # Barcodes Product as published 1 03573026111021Description, Reference No. (UDI No.): MINI VIDAS ANALYSER EU, 99174 (03573026111021) 2 03573026111045MINI VIDAS ANALYSER US, 99175 (03573026111045) 3 03573026118662MINI VIDAS 100-120 VOLT VDE/CE, 99733 (03573026118662) 4 03573026118655MINI VIDAS 200-240 VOLT VDE/CE, 99734 (03573026118655) 5 03573026140441MINI VIDAS BLUE 110 / 220 V, 99737 (03573026140441) 6 03573026140465MINI VIDAS ARKRAY ANALYZER, 99739 (03573026140465) 7 03573026351656MINI VIDAS, 410416 (03573026351656) 8 03573026029180MINI VIDAS, W1421 (03573026029180) 9 03573026553319MINIVIDAS INDUSTRY US, 421001 (03573026553319) - Amount recalled
- 1,866 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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