FDANovember 23, 2016device
MagSIL (NucliSENS easyMAG Magnetic Silica), Product Usage: The NucliSENS¿ easyMAG¿ system is an in vitro diagnostic medical device and is intended for the automated isolation (purification and concentration) of total nucleic acids (RNA/DNA) from biological specimens.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
A drift of the performance with the BK test (BK virus, worst case application) was observed for some silica batches of Magnetic Silica (MagSil). This is the same issue as in recall Z-2342-2016.
What to do
FDA enforcement status: Terminated
Brands named
biomerieux sabiomerieux
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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