113 results
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80ms
·
Sources: EU EUDAMED, US FDA
FISHERBRAND
FDA Adverse Event
Malfunction
·THERMO FISHER SCIENTIFIC, INC·Product code FMH·June 7, 2024
*
FDA Adverse Event
Malfunction
·THERMO FISHER SCIENTIFIC INC·Product code LIO·November 16, 2007
CYTORICH
FDA Adverse Event
Malfunction
·THERMO FISHER SCIENTIFIC, INC·Product code LEA·December 18, 2024
CYTORICH RED WHITE CAPS
FDA Adverse Event
Malfunction
·THERMO FISHER SCIENTIFIC, INC·Product code LEA·December 10, 2024
THERMOFISHER EPREDIA
FDA Adverse Event
Malfunction
·THERMO FISHER SCIENTIFIC INC.·Product code IDZ·December 27, 2019
Pacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI 00845275000870, 1 x 5 mL, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company, LLC, a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA
FDA Enforcement
Class II
·Terminated·Fisher Diagnostics·August 2, 2017
Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI 00845275000863, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company LLC ,a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA --- For determination of Fibrinogen Degradation products in serum and urine.
FDA Enforcement
Class II
·Terminated·Fisher Diagnostics·August 2, 2017
Pacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI 00845275000870, 1 x 5 mL, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company, LLC, a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA
FDA Recall
Terminated
·Fisher Diagnostics·Product code KQJ·May 19, 2017
TAQPATH COVID-19 COMBO KIT
FDA Adverse Event
Malfunction
·THERMO FISHER SCIENTIFIC, INC. / LIFE TECHNOLOGIES CORPORATION·Product code QJR·October 5, 2021
Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI 00845275000863, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company LLC ,a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA --- For determination of Fibrinogen Degradation products in serum and urine.
FDA Recall
Terminated
·Fisher Diagnostics·Product code KQJ·May 19, 2017
TAQPATH COVID-19 COMBO KIT
FDA Adverse Event
Injury
·THERMO FISHER SCIENTIFIC, INC. / APPLIED BIOSYSTEMS / LIFE TECHNOLOGIES CORPORATION·Product code QJR·March 1, 2021
Remel TB Potassium Permanganate (.5% Aqueous) 40192, packaged in 250 ml bottles, 5/pkg. A stain for use in qualitative procedures as a counterstain in the fluorescent microscopic detection of mycobacteria.
FDA Recall
Terminated
·Remel Inc·Product code JTS·October 29, 2014
VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code CEW·September 29, 2022
VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code CEW·November 18, 2022
VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code CEW·November 1, 2022
VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code CEW·November 18, 2022
VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code CEW·November 22, 2022
VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code CEW·November 15, 2022
VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code CEW·October 10, 2022
VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code CEW·November 18, 2022