FDAOctober 18, 2017device
NucliSENS Lysis Buffer Extended lot for RES 76675
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Elute may become colored due to the residual presence of heme group origination from hemoglobin present in whole blood samples as well as dried spot (DBS) samples. This can potentially cause the inhibition of PCR reactions and result in an uninterpretable test result. If using an Internal Control (IC) in the extraction process the IC could potentially be inhibited as well and invalidate test results.
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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