378 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Prescription eyeglass safety lenses. Vision correction
FDA Recall
Terminated
·Eyemart Express Ltd·Product code HQG·September 12, 2014
Safety glasses made with "Rage" frames manufactured between February 20, 2014 and February 25, 2014. The color of the frames of the recalled glasses were either white or black. Safety Eye wear
FDA Recall
Terminated
·Wal Mart Stores, Inc·Product code HQG·February 26, 2014
Polycarbonate prescription single vision lenses for use in sport goggles. To be worn by a customer in a sport goggle frame to provide corrective refraction in accordance with the customer's prescription. Per the customer's request, some of the devices may also provide protection from bright sunlight.
FDA Recall
Terminated
·Luxottica Optical Manufacturing·Product code HQG·June 30, 2010
Frames Direct Prescription Spectacle Lenses included in the frame brands
FDA Recall
Terminated
·Frames Direct·Product code HQG·March 18, 2020
Alere" hCG Combo Cassette (20/10 mIU/mL) Kit. Product Usage: The AlereTM hCG Combo (20/10 mIU/mL) test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine, as an aid in the early detection of pregnancy. It is for healthcare professionals only.
FDA Enforcement
Class II
·Terminated·Alere San Diego, Inc.·June 5, 2013
Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 4582105026) The SP hCG Cassette Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in the early detection of pregnancy. This test is for professional use.
FDA Enforcement
Class III
·Terminated·Alere San Diego, Inc.·May 29, 2013
CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CONSULT Diagnostics hCG Controls are intended to validate the performance of qualitative hCG urine procedures and immunochromatographic devices.
FDA Enforcement
Class III
·Terminated·Biochemical Diagnostics Inc·December 2, 2015
1) VITROS¿ Immunodiagnostic Products Total Beta-hCG II Reagent Pack (Unique Device Identifier No. 10758750002320, 20758750002327) and the 2)VITROS¿ Immunodiagnostic Products Total Beta-hCG II Calibrators (Unique Device Identifier No. 10758750002337, 20758750002334); For quantitative measurement of human chorionic gonadotropin (hCG) and its beta subunit in human serum and plasma.
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·June 1, 2016
In vitro Diagnostic-Clinitest hCG Cassette Pregnancy Test, Radio immunoassay for Human Chorionic Gonadotropin (hCG) test system Product Number: 1760 The Clinitest hCG Pregnancy Test is for in vitro diagnostic use as a qualitative method in the rapid detection of human chorionic gonadotropin (hCG) in urine specimens.
FDA Recall
Terminated
·Siemens Medical Solutions Diagnostics·Product code JHI·April 4, 2008
Alere" hCG Combo Cassette (20/10 mIU/mL) Kit. Product Usage: The AlereTM hCG Combo (20/10 mIU/mL) test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine, as an aid in the early detection of pregnancy. It is for healthcare professionals only.
FDA Recall
Terminated
·Alere San Diego, Inc.·Product code JHI·April 16, 2013
HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and hysterosalpingography, gynecological use.
FDA Enforcement
Class II
·Terminated·Catheter Research, Inc·April 29, 2015
NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat. No. VPT1-CASS Product Usage: pregnancy test
FDA Enforcement
Class II
·Terminated·Ekla Corporation·July 18, 2018
CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CONSULT Diagnostics hCG Controls are intended to validate the performance of qualitative hCG urine procedures and immunochromatographic devices.
FDA Recall
Terminated
·Biochemical Diagnostics Inc·Product code JJX·September 14, 2015
Clinitest hCG Cassette Pregnancy Test, Radio immunoassay for Human Chorionic Gonadotropin (hCG) test system Product Number: 1760
FDA Recall
Terminated
·Siemens Medical Solutions Diagnostics·Product code JHI·October 17, 2007
HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and hysterosalpingography, gynecological use.
FDA Recall
Terminated
·Catheter Research, Inc·Product code HGS·April 7, 2015
Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG Part number 020361 The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay
FDA Enforcement
Class II
·Terminated·Tosoh Bioscience Inc·September 23, 2020
Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 4582105026) The SP hCG Cassette Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in the early detection of pregnancy. This test is for professional use.
FDA Recall
Terminated
·Alere San Diego, Inc.·Product code JHI·January 21, 2013
Access Immunoassay Systems Total hCG. The Access Total hCG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total hCG levels in human serum and plasma using the Access Immunoassay Systems.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code JHI·March 5, 2009
IMx Total B-hCG Reagent is composed of one bottle of Anti B-hCG Coated Microparticles, one bottle of Anti B-hCG Alkaline Phosphatase Conjungate, one bottle of 4-Methylumbelliferyl Phosphate and one bottle of Specimen Diluent.
FDA Recall
Terminated
·Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila·Product code JHI·April 10, 2007
Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG Part number 020361 The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code JIT·August 7, 2020