972 results
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14ms
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Sources: EU EUDAMED, US FDA
Abbott Point of Care, i-STAT E3+ Cartridge, (NA K Hct); List No: 06F08-01; Part No: 120500; Abbott Point of Care Inc., East Windsor, NJ 08520 USA; Product of Canada.
FDA Recall
Terminated
·Abbott Point of Care Inc.·Product code JGS·October 18, 2007
Abbott Point of Care, i-STAT EC4+ Cartridge; (NA K Glu Hct); List No: 06F07-01; Part No: 121500; Abbott Point of Care Inc., East Windsor, NJ 08520 USA; Product of Canada.
FDA Recall
Terminated
·Abbott Point of Care Inc.·Product code JGS·October 18, 2007
Abbott Point of Care, i-STAT CREA Cartridge (Creatine/Crea); List No: 06F10-01; Part No: 320100; Abbott Point of Care Inc., East Windsor, NJ 08520 USA; Product of Canada.
FDA Recall
Terminated
·Abbott Point of Care Inc.·Product code JGS·October 18, 2007
Abbott Point of Care, i-STAT G Cartridge; (Glucose/Glu); List No: 06F09-01; Part No: 120100; Abbott Point of Care, Inc., East Windsor, NJ 08520, USA; Product of Canada.
FDA Recall
Terminated
·Abbott Point of Care Inc.·Product code JGS·October 18, 2007
Abbott Point of Care, i-STAT 6+ Cartridge (Na K CL BUN/Urea GLU Hct); List No: 06F05-01; Part No: 121000; Abbott Point of Care Inc., East Windsor, NJ 08520 USA; Product of Canada.
FDA Recall
Terminated
·Abbott Point of Care Inc.·Product code JGS·October 18, 2007
Abbott Point of Care, i-STAT EC8+ Cartridge; (NA K CL Glu pH PCO 2 UN/Urea Hct); List No: 06F04-01; Part No: 12500; Abbott Point of Care Inc., East Windsor, NJ 08520, USA; Product of Canada.
FDA Recall
Terminated
·Abbott Point of Care Inc.·Product code JGS·October 18, 2007
i-STAT DE handheld data processing module for clinical use, Software Version 2.8, List Number:08K46-01115200 (UDI: 00054749001255)
FDA Recall
Terminated
·Abbott Point Of Care Inc.·Product code JQP·September 12, 2017
Active I-PTH ELISA, Part Number: DSL-10-8000 The DSL-10-80000 ACTIVE I-PTH Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of I-PTH in serum or plasma. This assay is intended for in vitro diagnostic use as an aid in the diagnosis of hyperparathyroidism.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code CEW·April 22, 2010
Active I-PTH Enzyme-Linked Immunosorbent Assay(ELISA), Part Number: DSL-10-8000 The DSL-10-8000 ACTIVE I-PTH Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of I-PTH in serum or plasma. This assay is intended for in vitro diagnostic use as an aid in the diagnosis of hyperparathyroidism
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code CEW·March 4, 2010
i-STAT PT/INR Cartridge Abbott Point of Care, Princeton, NJ
FDA Recall
Terminated
·Abbott Point of Care Inc.·Product code GJS·May 5, 2010
putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010, PUTTY
FDA Recall
Terminated
·Cerapedics, Inc.·Product code NOX·April 14, 2022
Abbott Point of Care i-Stat cTnI cartridge. The i-Stat cardiac troponin I (cTnI) test is an in vitro diagnostic test for the quantitive measurement of cardiac troponin I (cTnI) in whole blood or plasma. Measurements of cardiac troponin I are used in the diagnosis and treatment of myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes with respect to the relative risk of mortality.
FDA Recall
Terminated
·Abbott Point of Care Canada Limited·Product code MMI·November 1, 2012
Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131 Product Usage: Philips Single-Patient-Use ECG lead sets for bedside monitoring are available in 5-lead configuration
FDA Recall
Terminated
·Philips North America, LLC·Product code DSA·July 19, 2019
Zimmer Dental, Drill stop kit, REF DSKIT, for use with dental implants.
FDA Recall
Terminated
·Zimmer Inc.·Product code OFY·May 18, 2010
i-STAT ACT Celite Cartridges in vitro diagnostic test used to monitor moderate and high-level heparin therapy through analysis of arterial and venous whole blood samples.
FDA Recall
Terminated
·Abbott Point Of Care Inc.·Product code JBP·October 6, 2010
i-STAT ACT Kaolin Cartridges in vitro diagnostic test which uses fresh whole blood to monitor high-dose heparin anticoagulation frequently associated with cardiovascular surgery.
FDA Recall
Terminated
·Abbott Point Of Care Inc.·Product code JBP·October 6, 2010
Access Immunoassay Systems CORTISOL, Part Number: 33600
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code CGR·February 17, 2010
Access Immunoassay Systems PROGESTERONE, Part Number: 33550
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code JLS·February 17, 2010
Product is labeled in part: "***is immunosimplicity***HSV 1&2 IgM***Enzyme Immunoassay Test Kit***For the Detection of HSV 1&2 IgM antibodies***Catalog No: 720-350***Exp. Date:***Contains Sufficient for 96 Tests***C - Corrosive Harmful***Lot No: ***For In Vitro Diagnostic Use***Caution, consult accompanying documents.***Manufacturer***Diamedix***A Subsidiary of IVAX Diagnostics, Inc. MIAMI, FL 33127 USA-1-800-327-4565***Biohazard***" The Is-HSV 1&2 IgM test kits are packaged in cardboard boxes with individual components secured within a foam insert. The Diamedix Is-HSV 1&2 IgM Test Kit is intended for the qualitative detection of IgM antibodies to herpes simplex virus (HSV) type 1 and/or type 2 in human serum by indirect enzyme immunoassay. This test can aid in the diagnosis of a primary or reactived infection with HSV. The performance of this assay has not bee established for use in neonates, infants, or on cord blood, and immunocompromised patients.
FDA Recall
Terminated
·Diamedix Corporation·Product code LGC·January 16, 2012
Product is labeled in part: "***is immunosimplicity***ENA-6 Screen***Enzyme Immunoassay Test Kit***Catalog No: 720-230***Exp. Date: 2012-05-31***Contains Sufficient for 96 Tests***C - Corrosive Harmful***Lot No: S0000***For In Vitro Diagnostic Use***Caution, consult accompanying documents***Manufacturer DIAMEDIX***a Subsidiary of IVAX Diagnostics, Inc.***Miami, FL 33127 USA-1-800-327-4565***Biohazard***" For the qualitative screening of human IgG antibodies to extractable nuclear antigens (ENA) in human serum by indirect enzyme immunoassay as an aid in the diagnosis of certain autoimmune disorders. This test system screens for antibodies to Sm, Sm/RNP, SSA, SSB, Scl-70 and Jo-1 in one well. Positive samples should be evaluated further using tests designed for each ENA antibody.
FDA Recall
Terminated
·Diamedix Corporation·Product code LLL·June 8, 2011