FDAJanuary 4, 2018device
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 m...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
biomerieux
UPCs
0357302613357303573026133580035730261092570357302611406003573026114084035730261404270357302602967803573026351663035730261216310357302603029203573026553319
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAVITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam (mev01n) o Imipenem (ipm05n) o Imipenem/Relebactam (ipr01n); CARD NAME/ PRODUCT REFERENCE: AST-N399 423701 AST-N402 423644 AST-N403 423645 AST-N404 423664 AST-N405 ...2026-01-05
- FDAVITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. Export only2025-06-26
- FDAVITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b) AST-GN95, REF 421982; c) AST-GN99, REF 423102; d) AST-N390, REF 423340; e) AST-N391, REF 423341; f) AST-N392, REF 423342; g) AST-N395, REF 423491; h) AST-N401, REF 423643; i) AST...2024-03-14
- FDAMYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments for ID/AST and blood culture activities and the laboratory information system (LIS).2023-02-06
- FDAVITEK 2 REAGENT GN TEST KIT VTK2 20 CARDS, CATALOG 213412022-11-09
- FDAVITEK 2 REAGENT GP TEST KIT VTK2 20 CARDS, CATALOG 213422022-11-09
- FDATEMPO REAGENTS TEMPO CONTROL KIT , CATALOG 800002022-11-09
- FDAVIDAS CLINICALVIDAS VARICEL. ZOSTER IGG 60 T, CATALOG 302172022-11-09
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