133 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Amplicor [3] AV-HRP. (Avidin-HRP (Horseradish Peroxidase) BGG Conjugate.) Kit: Amplicor HCV Detection Kit, v2.0
FDA Recall
Terminated
·Roche Molecular Systems Inc·Product code MZP·July 7, 2004
Amplicor [3] AV-HRP, Avidin-HRP (Horseradish Peroxidase) BGG Conjugate. Kit: AmpliCap HCV MonitorTest, Export, RUO.
FDA Recall
Terminated
·Roche Molecular Systems Inc·Product code MZP·July 7, 2004
Amplicor [3] AV-HRP. (Avidin-HRP (Horseradish Peroxidase) BGG Conjugate.) Kit: Amplicor CT/NG CT Detection Kit
FDA Recall
Terminated
·Roche Molecular Systems Inc·Product code MKZ·July 7, 2004
Amplicor [3] AV-HRP. (Avidin-HRP (Horseradish Peroxidase) BGG Conjugate.) Kit: Amplicor CT/NG NG Detection Kit
FDA Recall
Terminated
·Roche Molecular Systems Inc·Product code LSL·July 7, 2004
Amplicor [3] AV-HRP, Avidin-HRP (Horseradish Peroxidase) BGG Conjugate. Kit: AMPLICOR M. avium Detection Kit, Export,RUO.
FDA Recall
Terminated
·Roche Molecular Systems Inc·July 7, 2004
Amplicor [3] AV-HRP, Avidin-HRP Horseradish Peroxidase) BGG Conjugate. Kit: AMPLICOR NG Detection Kit, Export IVD/CE.
FDA Recall
Terminated
·Roche Molecular Systems Inc·Product code LSL·July 7, 2004
Amplicor [3] AV-HRP, Avidin-HRP (Horseradish Peroxidase) BGG Conjugate. Kit: AMPLICOR IC Detection Kit, Export, IVD/CE.
FDA Recall
Terminated
·Roche Molecular Systems Inc·July 7, 2004
Amplicor [3] AV-HRP. (Avidin-HRP (Horseradish Peroxidase) BGG Conjugate.) Kit: Amplicor IC Detection Kit, 96 test [General Purpose]
FDA Recall
Terminated
·Roche Molecular Systems Inc·July 7, 2004
Amplicor [3] AV-HRP, Avidin-HRP (Horseradish Peroxidase) BGG Conjugate. Kit: AMPLICOR MTB Detection Kit, Gen 2 Export IVD/CE.
FDA Recall
Terminated
·Roche Molecular Systems Inc·Product code MWA·July 7, 2004
Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit; Catalog number M4U534L; For In Vitro Use Immunology: MACH 4 Universal HRP-Polymer is a horseradish peroxidase (HRP)-antibody conjugate system intended for use in the detection of mouse lgG and lgM, and rabbit IgG primary antibodies on formalin-fixed, paraffin-embedded (FFPE) tissues in an immunohistochemistry (IHC) procedure. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.
FDA Enforcement
Class III
·Terminated·Biocare Medical, LLC·April 27, 2016
Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit; Catalog number M4U534L; For In Vitro Use Immunology: MACH 4 Universal HRP-Polymer is a horseradish peroxidase (HRP)-antibody conjugate system intended for use in the detection of mouse lgG and lgM, and rabbit IgG primary antibodies on formalin-fixed, paraffin-embedded (FFPE) tissues in an immunohistochemistry (IHC) procedure. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.
FDA Recall
Terminated
·Biocare Medical, LLC·Product code NJT·March 31, 2016
APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; in vitro diagnostic. Distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360 (address now in Seabrook, TX 77856).
FDA Recall
Terminated
·Louisville Apl Diagnostics Inc·Product code MID·July 18, 2006
4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number: HP604H
FDA Enforcement
Class II
·Terminated·Biocare Medical, LLC·June 17, 2020
APhL HRP IgM ELISA Kit; Ref. #LAPL-K-HRP-001M; distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360-- Quality Control Fact Sheets for the Louisville APL Diagnostics, Inc. --(current address now in Seabrook, TX 77586).
FDA Recall
Terminated
·Louisville Apl Diagnostics Inc·Product code MID·October 6, 2005
APhL HRP IgG ELISA Kit; Ref. #LAPL-K-HRP-001G; distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360- Quality Control Fact Sheets for the Louisville APL Diagnostics, Inc.-- (current address now in Seabrook, TX 77586).
FDA Recall
Terminated
·Louisville Apl Diagnostics Inc·Product code MID·October 6, 2005
APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360- Quality Control Fact Sheets for the Louisville APL Diagnostics, Inc. (address now in Seabrook, TX 77586).
FDA Recall
Terminated
·Louisville Apl Diagnostics Inc·Product code MID·October 6, 2005
EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.
FDA Enforcement
Class II
·Terminated·Dako North America Inc.·November 11, 2015
4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number: HP604H
FDA Recall
Terminated
·Biocare Medical, LLC·Product code NJT·October 10, 2019
Super Sensitive Link-Label IHC Detection System/Mega Volume, RTU Multi-Link-HRP, REF/Cat. No. QP300-XAK, Kit containing reagent vials, Bio-Genex, San Ramon, CA.
FDA Recall
Terminated
·Biogenex Laboratories·Product code NJT·October 3, 2006
VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092 Immunohistochemistry (IHC) for in vitro diagnostic use.
FDA Enforcement
Class I
·Terminated·Ventana Medical Systems Inc·September 26, 2018