17 results
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40ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Parker Eclipse Probe Cover, Latex Free, REF 38-01, 10 Eclipse Probe Covers, Size: 2.37/1.75"W x 9.5"L (60/44 mm x 241 mm), Lot #D424, Expiry date 04/2016, Pre-gelled inside with Aquasonic 100 Ultrasound Transmission Gel Product Usage: For use as a protective cover for medical ultrasound probes/transducers.
FDA Recall
Terminated
·Parker Laboratories, Inc.·Product code IYO·August 6, 2014
Parker Eclipse Probe Cover, Latex Free, REF 38-01, 10 Eclipse Probe Covers, Size: 2.37/1.75"W x 9.5"L (60/44 mm x 241 mm), Lot #D424, Expiry date 04/2016, Pre-gelled inside with Aquasonic 100 Ultrasound Transmission Gel Product Usage: For use as a protective cover for medical ultrasound probes/transducers.
FDA Enforcement
Class II
·Terminated·Parker Laboratories, Inc.·November 5, 2014
Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case
FDA Recall
Terminated
·Parker Laboratories, Inc.·Product code IYO·April 13, 2017
Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case
FDA Enforcement
Class II
·Terminated·Parker Laboratories, Inc.·May 16, 2018
The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220. It is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The Bio-Rad MONOLISA Anti-HBs EIA is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection in individuals prior to or following HBV vaccination or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection.
FDA Recall
Terminated
·Bio-Rad Laboratories·Product code LOM·July 27, 2012
ST-AIA PACK PA; Part Number: 025263 Assay, Tumor Marker
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code LTJ·March 5, 2018
ST-AIA PACK 27.29; Part Number: 025202 Assay, Tumor Marker
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code MOI·March 5, 2018
ST-AIA PACK Cystatin C; Part Number: 025217 Assay, Kidney Marker
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code NDY·March 5, 2018
ST-AIA PACK CA 19-9; Part Number: 025271 Assay, Tumor Marker
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code NIG·March 5, 2018
ST-AIA PACK Myoglobin; Part Number: 025297 Assay, Cardiac Marker
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code DDR·March 5, 2018
ST-AIA PACK AFP; Part Number: 025252 Assay, Tumor Marker
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code LOJ·March 5, 2018
ST-AIA PACK CEA; Part Number: 025254 Assay, Tumor Marker
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code DHX·March 5, 2018
ST-AIA PACK BMG; Part Number:025259 Assay, Tumor Marker
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code JZG·March 5, 2018
ST-AIA PACK CK-MB; Part Number: 025269 Assay, Cardiac Marker
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code JHX·March 5, 2018
ST-AIA PACK cTnI 2nd Gen; Part Number: 025205 Assay, Cardiac Marker
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code MMI·March 5, 2018
Abbott RealTime HBV Assay, List 2N40, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60018 USA The Abbott RealTime HBV is an in vitro polymerase chain reaction (PCR) assay for the quantitation of Hepatitis B Virus (HBV) DNA in human plasma or serum from HBV-infected individuals. The Abbott RealTime HBV assay is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of disease prognosis and for use as an aid in assessing viral response to antiviral treatment as measured by changes in plasma or serum HBV DNA levels. This assay is not intended for use as a screening test for HBV or as a diagnostic test to confirm the presence of HBV infection.
FDA Recall
Terminated
·Abbott Molecular·Product code MKT·December 20, 2010
Abbott RealTime HIV-1 Assay, List 6L18, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60018 USA The Abbott RealTime HIV-1 assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for the quantitation of Human Immunodeficiency Virus type 1 (HIV-1) on the automated m2000 System in human plasma from HIV-1 infected individuals over the range of 40 to 10,000,000 copies/mL. The Abbott RealTime HIV-1 assay is intended for use in conjunction with clinical presentation and other laboratory markers for disease prognosis and for use as an aid in assessing viral response to antiretroviral treatment as measured by changes in plasma HIV-1 RNA levels. This assay is not intended to be used as a donor screening test for HIV-1 or as a diagnostic test to confirm the presence of HIV-1 infection.
FDA Recall
Terminated
·Abbott Molecular·Product code MTL·December 20, 2010