17 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
×
VIDAS Lyme IgG II (LYM), REF 417401
FDA Recall
Open, Classified
·bioMerieux, Inc.·Product code LSR·September 22, 2021
VIDAS RUB IgG (RBG), REF 30226
FDA Recall
Open, Classified
·bioMerieux, Inc.·Product code LFX·September 22, 2021
VIDAS Lyme IgM II (LYM), REF 416436
FDA Recall
Open, Classified
·bioMerieux, Inc.·Product code LSR·September 22, 2021
VIDAS LH, REF 30406-01
FDA Recall
Open, Classified
·bioMerieux, Inc.·Product code CEP·September 22, 2021
VIDAS SARS-COV-2 IgG, Ref 423834-01
FDA Recall
Open, Classified
·bioMerieux, Inc.·Product code QKO·September 22, 2021
VIDAS B.R.A.H.M.S. PROCALCITONIN PCT, REF 30450-01
FDA Recall
Open, Classified
·bioMerieux, Inc.·Product code PRI·September 22, 2021
VIDAS Estradiol II, REF 30431-01
FDA Recall
Open, Classified
·bioMerieux, Inc.·Product code CHP·September 22, 2021
VIDAS TOXO IgG Avidity (TXGA), REF 30222-01
FDA Recall
Open, Classified
·bioMerieux, Inc.·Product code LGD·September 22, 2021
VIDAS SARS-COV-2 IgM, Ref 423833-01
FDA Recall
Open, Classified
·bioMerieux, Inc.·Product code QKO·September 22, 2021
VIDAS Measles IgG (MSG), REF 30219
FDA Recall
Open, Classified
·bioMerieux, Inc.·Product code LJB·September 22, 2021
VIDAS DEX@, Dimer Exclusion II, REF 30455-01
FDA Recall
Open, Classified
·bioMerieux, Inc.·Product code DAP·September 22, 2021
VIDAS Clostridium Difficile GDH, REF 30125-01
FDA Recall
Open, Classified
·bioMerieux, Inc.·Product code MCB·September 22, 2021
VIDAS Mumps IgG (MPG), REF 30218
FDA Recall
Open, Classified
·bioMerieux, Inc.·Product code LJY·September 22, 2021
VIDAS PRG Progesterone, REF 30409-01
FDA Recall
Open, Classified
·bioMerieux, Inc.·Product code JLS·September 22, 2021
VIDAS FSH, REF 30407-01
FDA Recall
Open, Classified
·bioMerieux, Inc.·Product code CGJ·September 22, 2021
VIDAS Clostridium Difficile Toxin A&B, CDAB,REF 30118-01
FDA Recall
Open, Classified
·bioMerieux, Inc.·Product code LLH·September 22, 2021
FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base which includes barcode scanner, touch screen computer and USB ports. The BioFire FilmArray Torch (BioFire Torch) is an automated in vitro diagnostic (IVD) device intended for use with FDA-cleared or approved IVD BioFire FilmArray Panels. Additional Part/Reference Numbers as part of the system: - HTFA-ASY-0102: BIOFIRE TORCH Duplex. This is a plastic component that covers the BIOFIRE TORCH Modules. The BIOFIRE TORCH Duplex is only necessary if the system includes more than two modules. - HFTA-SUB-0103: BIOFIRE TORCH Module. The BIOFIRE reagent pouches are inserted into the modules.
FDA Recall
Open, Classified
·BioFire Diagnostics, LLC·Product code NSU·October 17, 2023