FDANovember 9, 2021device
RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
There is an error in the new version of the package insert. The Reading Table lists the incorrect color for a negative result for the CIT test.
What to do
FDA enforcement status: Terminated
Brands named
biomerieux
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
- FDAVIDAS CLINICAL VIDAS MEASLES IGG 60TESTS, CATALOG 302192022-11-09
- FDATEMPO REAGENTS TEMPO CONTROL KIT , CATALOG 800002022-11-09
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