97 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Jarvik 2000 Ventricular Assist System external components: JHI-212 Y Cable, JHI-202 Lithium-ion Battery Cable, JHI-204 Extensions Cable, JHI-201 Pedestal Cable
FDA Recall
Terminated
·Jarvik Heart Inc·Product code DSQ·October 15, 2018
Jarvik 2000 Ventricular Assist System external components: JHI-212 Y Cable, JHI-202 Lithium-ion Battery Cable, JHI-204 Extensions Cable, JHI-201 Pedestal Cable
FDA Enforcement
Class II
·Terminated·Jarvik Heart Inc·December 26, 2018
Clearview hCG Combo Waived for urine & Moderate for serum, Wampole Laboratories, ABI List No/Product No. 6026KCV; Contents 30 Individually pouched test cassettes with disposable pipettes, 1 Directional Insert; Inverness Medical Professional Diagnostics Group; Marketed by Wampole Laboratories, 2 Research Way, Princeton NJ 08540 USA
FDA Recall
Terminated
·Applied Biotech Inc·Product code JHI·September 28, 2006
Mainline hCG Accuracy Check, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 3c1001.
FDA Recall
Terminated
·Mainline Technology, Inc.·Product code JHI·August 18, 2008
AxSYM total B-hCG Reagent is composed of one bottle of Coated Microparticles, one bottle of Alkaline Phosphatase Conjugate and one bottle of Specimen Diluent.
FDA Recall
Terminated
·Abbott Health Products, Inc.·Product code JHI·March 24, 2005
Signify hCG Serum/Urine 30 Test Kit, Abbott List No. 07K09-30, ABI List No. 6026KSI, Lot# 84936, Exp 02/10/2007
FDA Recall
Terminated
·Applied Biotech Inc·Product code JHI·May 5, 2006
Mainline Confirms hCG Serum/Urine III, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 3029-25.
FDA Recall
Terminated
·Mainline Technology, Inc.·Product code JHI·August 18, 2008
IMx total B-hCG Reagent is composed of one bottle of Coated Microparticles, one bottle of Alkaline Phosphatase Conjugate, one bottle of 4 Methylumbelliferyl Phosphate and one bottle of Specimen Diluent
FDA Recall
Terminated
·Abbott Health Products, Inc.·Product code JHI·March 24, 2005
Siemens CLINITEST hCG -Pregnancy Test (qualitative), Radio immunoassay,Human Chorionic Gonadotropin (hCG) test system. Package of 25. Product Code 1760/ Catalog# 06484105). 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 Healthcare Diagnostics·Product code JHI·December 15, 2011
ST-AIA PACK HCG; Part Number: 025261 Assay, Reproductive Hormone
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code JHI·March 5, 2018
AxSYM Total B-hCG Reagent Pack
FDA Recall
Terminated
·Abbott Health Products, Inc.·Product code JHI·July 7, 2004
f.y.i. hCG Urine one-step pregnancy test, Carmel Diagnostics, LLC, Naples, FL; Catalog # 43065.
FDA Recall
Terminated
·Mainline Technology, Inc.·Product code JHI·August 18, 2008
AxSYM Total B-hCG Reagent List 7A59-22 is composed of one bottle of Anti B-hCG Coated Microparticles, one bottle of Anti- B- hCG Alkaline Phosphatase Conjugate and one bottle of Specimen Diluent. REF 7A59-22. 100 Tests. For In Vitro Diagnostic Use.
FDA Recall
Terminated
·Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila·Product code JHI·April 10, 2007
Fisher Healthcare Sure-Vue Serum/Urine hCG-STAT; in vitro diagnostic test; Catalog Number: FHC-A202; Product Codes: FHC-A202-KFI3O & FHC-A202-KFI5O; Inverness Medical Professional Diagnostics, San Diego, CA 92121.
FDA Recall
Terminated
·Innovacon Inc·Product code JHI·October 1, 2007
NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat. No. VPT1-CASS Product Usage: pregnancy test
FDA Recall
Terminated
·Ekla Corporation·Product code JHI·October 20, 2016
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
Mainline Confirms Strep A DOTS, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 4040.
FDA Recall
Terminated
·Mainline Technology, Inc.·Product code JHI·August 18, 2008
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
ICON 25 hCG test kit.
FDA Recall
Terminated
·Beckman Coulter Inc·Product code JHI·December 22, 2003
AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21
FDA Recall
Terminated
·Abbott Health Products, Inc.·Product code JHI·August 24, 2004