Medical Device Recalls

Medical Device Recalls

Analyzing system consists of a small and portable analyzer and plastic microcuvettes. The growing economic pressures on hospitals, coupled with advances in diagnostic technologies, intensifying competition among suppliers and physicians, and changing consumer demands are shifting diagnostic testing from hospitals and commercial laboratories closer to the patient. Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; Liquid Assayed Integrated Immunoassay Contro… Albumin, Alkaline Phosphatase, ALT/SGPT, Ammonia, Amylase, AST/SGOT, Bilirubin, Blood Gases, BUN (Blood Urea Nitrogen), Calcium, Cholesterol, Cholinesterase, Creatinine, CK-MB, Electrolytes (Carbon Dioxide/Bicarbonate, Chloride, Potassium, Sodium), Ferritin, Follate/Folic Acid, Fructosamine, GGT, Glucose, HDL, Iron, LDH, Magnesium, Phosphorus, Potassium, Protein, Sodium, Triglycerides, Troponin, Uric Acid, Urinalysis, Vitamin B12. AIDS/HIV, Adenovirus, Aeromonads, Bartonella, Blastocystis Hominis, Campylobacter, Candida, Chancroid, Chlamydia, Clostridium, Coronavirus, Coxsackievirus, Cryptosporidium, Cyclospora, CMV, E. 2 Oct-10-2012 Alere San Diego, Inc. 2 Dec-22-2012 Beckman Coulter Inc.

ACTH, AFP, Beta-2 Microglobulin, CA 15-3/27.29, CA 19-9, CA 125, Calcitonin, Cathepsin, CEA, Chromogranin, Colon-Specific Antigen, Cytokeratins, Estrogen Receptor, Ferritin, Gastrin, HCG, Insulin, Interferons, Interleukins, Lymphocyte Subtyping, Neuron-Specific Enolase, Nucleolar, Occult Blood, Oncogenes, Pancreatic Oncofetal Antigen, Pap Smear, Parathyroid Hormone, Progesterone Receptor, Prostatic Acid Phosphatase, Prostatic Specific Antigen, S-100 Protein, Serotonin, Sialic Acid, Squamous Cell Carcinoma Ag, TDT, Thymidine Kinase, Thyroglobulin, Tissue Polypeptide Antigen, and others. Access Folate WHO Calibrators, Part Number: A98033. Activated Clotting Time (ACT) (1), Activated Protein C Resistance, Activated PTT (APTT), Alpha 2-Antiplasmin, Antithrombin III, Bleeding Time, D-Dimer, Factor II, Factor V, Factor V Leiden, Factor VII, Factor VIII,  Factor IX, Factor Ixa, Factor X (Stuart Factor), Factor Xa, Factor XI, Factor XII, Factor XIII, Fibrin Degradation Products, Fibrinogen, Fletcher Factor/Pre-Kallikrein Factor Activation, Heparin/Anti-Factor Xa, Heparin-Induced Thrombocytopenia, Plasmin, Plasminogen, Plasminogen Activator Inhib., Platelet Function/Aggregation, Protein C, Protein S, Prothrombin Mutation, Prothrombin Time (PT), Reptilase Time, Thrombin Time, Von Willebrand’s Factor Fav/Ag, and others. This report is based on a combination of primary and secondary sources of information, including review of recent technical and business publications, manufacturer product literature, industry analyst reports, and VPGMarketResearch’s proprietary data files. Access Folate Calibrators, Part Number: A14207. 1 Dec-07-2012 Verathon, Inc. 2 Oct-10-2012 Beckman Coulter Inc.

Alere Triage TOX Drug Screen 9 Panel, P/N: 94402. The Alere Triage TOX Drug Screen is a fluoresce… 2 Sep-26-2012 Alere San Diego, Inc. The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220… The UniCel Dx… These are software controlled MRI devices. Produc…
Medical Device Recalls

2 Aug-23-2012 Hitachi Medical Systems America Inc UniCel DxI 800 Access Immunoassay Systems, Part Numbers: Dxl 800: 937100; Dxl 800 Remanufactured: … 2 Aug-23-2012 Beckman Coulter Inc. UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical Systems, Part Numbers: DxC 660i: A648… 2 Nov-19-2012 Beckman Coulter Inc. UniCel DxI 600 Access Immunoassay Systems, Part Numbers: Dxl 600: A30260; Dxl 600 with spot B: A… 2 Aug-23-2012 Beckman Coulter Inc. Siemens ADVIA Centaur® Syphilis (SYPH) Assay , 200 ReadyPack Reference Number 10492493 Product…

2 Aug-20-2012 Siemens Healthcare Diagnostics, Inc Alere Triage Tox+MTD Drug Screen, PN 94400 Product Usage: The Alere Triage TOX Drug Screen is a … 2 Jul-19-2012 Alere San Diego, Inc. 2 Oct-10-2012 Alere San Diego, Inc. 2 Jun-29-2012 Abbott Laboratories Product is labeled in part: “***is immunosimplicity***ENA-6 Screen***Enzyme Immunoassay Test Kit***… 2 May-21-2012 Diamedix Corporation Norco Shoulder Pulley Distributed by North Coast Medical, Gilroy, CA. Used to improve range of… 2 May-14-2012 North Coast Medical Inc ARCHITECT STAT Troponin-I Reagent Kit; list numbers 2K41-28 (500 test kit); an in-vitro diagnostic t…

2 May-10-2012 Abbott Laboratories Product is labeled in part: “***is immunosimplicity***HSV 1&2 IgM***Enzyme Immunoassay Test Kit***F… Access Folate Calibrators, Part Number: A14207. 3 May-08-2012 Zeus Scientific, Inc. VITROS® 4600 Chemistry System, Product Code: 6802445 Product Usage: Fo… 2 Apr-26-2012 Ortho-Clinical Diagnostics Triage TOX Drug Screen (MTD) Panel, Model # 94400. Type of Packaging: 25 individually pouched devic… 2 Apr-20-2012 Alere San Diego dba Biosite Innovacon Hemosense Inc Norco Folding Shower Bench; Features a nonskid surface and handholds for added security.

2 Oct-05-2012 Beckman Coulter Inc. 2 Apr-16-2012 North Coast Medical Inc Elecsys Troponin I Immunoassay For the in-vitro quantitative determination of cardiac troponin I … 1 Apr-11-2012 Roche Diagnostics Operations, Inc. Elecsys Troponin I STAT Immunoassay For the in-vitro quantitative determination of cardiac tropon… 1 Apr-11-2012 Roche Diagnostics Operations, Inc.

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Medical Device Recalls

Medical Device Recalls

VPGMarketResearch’s new report provides comprehensive analysis of the ten POC market segments, including their dynamics, size, growth, regulatory requirements, technological trends, competitive landscape, and emerging opportunities for instrument and consumable suppliers. pneumoni antigen in the urine of patients with pneumonia and in the cerebral spinal fluid (CSF) of patients with meningitis. – Review of leading chemistry, immunoassay, hematology and coagulation analyzers market by Abaxis, Abbott, Alfa Wasserman, Awareness Technologies, Beckman Coulter/Danaher, Becton Dickinson, Behnk Elektronik, Biocode, Bio/Data, bioMerieux, Cardiovascular Diagnostics, Carolina Chemistries, Diagnostica Stago, Diesse Ves Matic, Drew-Scientific, Helena Laboratories, Horiba, Instrumentation Laboratory, Inverness, ITC Hemochron, Medica, Menarini, Nihon Kohden, Nova Biomedical, Ortho-Clinical Diagnostics, Polymedco, Randox, Roche, Siemens, Sysmex, Teco Medical Instruments, Trinity Biotech, and other suppliers. Albumin, Alkaline Phosphatase, ALT/SGPT, Ammonia, Amylase, AST/SGOT, Bilirubin, Blood Gases, BUN (Blood Urea Nitrogen), Calcium, Cholesterol, Cholinesterase, Creatinine, CK-MB, Electrolytes (Carbon Dioxide/Bicarbonate, Chloride, Potassium, Sodium), Ferritin, Follate/Folic Acid, Fructosamine, GGT, Glucose, HDL, Iron, LDH, Magnesium, Phosphorus, Potassium, Protein, Sodium, Triglycerides, Troponin, Uric Acid, Urinalysis, Vitamin B12. Product Usage: The Triage TOX Drug Screen is a flu… Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Clinical System, UniCel … Pylori, Hepatitis (A, B, C, D, E), Herpes Simplex Virus, Human Herpes Virus-6 (HHV-6), Influenza, Legionella, Lyme disease, Pymphogranuloma, Malaria, Measles, Meningitis, Mononucleosis, Microsporidium, Mononucleosis, Mumps, Mycoplasma, Polyomaviruses, Parvovirus B19, Pneumonia, Polyomaviruses, Pseudomonas, Rabies, RSV, Rhinovirus, Rheumatoid Arthritis, Rotavirus , Rubella, Salmonellosis, Septicemia, Shigella, Staphylococci, Streptococci, Syphilis, Toxoplasmosis, Trichomonas, Tuberculois, Vibrio, West Nile, Yersenia.

The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative d… Cell Surface Markers (CD4/CD8/T&B Lymphocytes, CD34, Others), Chemotherapy Monitoring (Leukemia/Lymphoma, Others), HLA Typing, Sperm Analysis, Cell Cycle Kinetics, Cell Function Testing, Chromosomal Abnormalities, Fetal Cell Analysis, Granulocyte Function, Receptor DNA/RNA Analysis, Cell Culturing. Activated Clotting Time (ACT) (1), Activated Protein C Resistance, Activated PTT (APTT), Alpha 2-Antiplasmin, Antithrombin III, Bleeding Time, D-Dimer, Factor II, Factor V, Factor V Leiden, Factor VII, Factor VIII,  Factor IX, Factor Ixa, Factor X (Stuart Factor), Factor Xa, Factor XI, Factor XII, Factor XIII, Fibrin Degradation Products, Fibrinogen, Fletcher Factor/Pre-Kallikrein Factor Activation, Heparin/Anti-Factor Xa, Heparin-Induced Thrombocytopenia, Plasmin, Plasminogen, Plasminogen Activator Inhib., Platelet Function/Aggregation, Protein C, Protein S, Prothrombin Mutation, Prothrombin Time (PT), Reptilase Time, Thrombin Time, Von Willebrand’s Factor Fav/Ag, and others. 2 Oct-10-2012 Beckman Coulter Inc. 2 Dec-11-2012 Siemens Healthcare Diagnostics, Inc The GlideScope Video Laryngoscope (GVL) is a video laryngoscope that incorporates a high-resolution … 1 Dec-07-2012 Verathon, Inc. The COBAS 8000 data manager modular analyzer series (all versions) is a is a fully automated, rando…

2 Dec-07-2012 Roche Molecular Systems, Inc. DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Ch… 2 Sep-26-2012 Alere San Diego, Inc. UniCel Dxl 600 Access Immunoassay System, Part Numbers: A30260, A71460, and A71461. The UniCel Dx… 2 Nov-19-2012 Beckman Coulter Inc. UniCel Dxl 800 Access Immunoassay System, Part Numbers: 973100, A71456, and A71457.

The UniCel Dx… 2 Aug-23-2012 Beckman Coulter Inc. UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems, Part Numbers: A64871, A64903, A64935, A591… 2 Nov-19-2012 Beckman Coulter Inc. Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; Liquid Assayed Integrated Immunoassay Contro… 3 Nov-19-2012 Microgenics Corporation Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40,… 2 Nov-09-2012 Progressive Medical Inc Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40,…

2 Aug-20-2012 Siemens Healthcare Diagnostics, Inc Alere Triage Tox+MTD Drug Screen, PN 94400 Product Usage: The Alere Triage TOX Drug Screen is a … Product Usage: The Triage TOX Drug Screen is a flu… 2 Oct-10-2012 Alere San Diego, Inc. Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL) Pro… 2 Oct-10-2012 Siemens Healthcare Diagnostics, Inc. Access Folate WHO Calibrators, Part Number: A98033. 2 May-14-2012 North Coast Medical Inc ARCHITECT STAT Troponin-I Reagent Kit; list numbers 2K41-28 (500 test kit); an in-vitro diagnostic t…

2 Oct-10-2012 Beckman Coulter Inc. Access Folate Calibrators, Part Number: A14207. The Access Folate assay is a paramagnetic particl… 2 Oct-10-2012 Beckman Coulter Inc. IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of Packaging: 25 individually pouched devic… 2 Oct-10-2012 Immunodiagnostics Systems Ltd Active Renin IRMA Kit, Part Number DSL25100 Product Usage: The Renin IRMA; DSL25100 immunoradiom…
Medical Device Recalls

2 Oct-05-2012 Beckman Coulter Inc. IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070 The IMMAGE Immunochemist… 2 Oct-01-2012 Beckman Coulter Inc. Alere Triage TOX Drug Screen 9 Panel, P/N: 94402. 1 Apr-11-2012 Roche Diagnostics Operations, Inc. 2 Sep-26-2012 Alere San Diego, Inc. The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220…

2 Sep-17-2012 Bio-Rad Laboratories PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antib… 3 Aug-28-2012 Phadia US Inc UniCel DxI 600 Access Immunoassay Systems, Part Numbers: Dxl 600: A30260; Dxl 600 with spot B: A… 2 Aug-23-2012 Beckman Coulter Inc. UniCel DxI 800 Access Immunoassay Systems, Part Numbers: Dxl 800: 937100; Dxl 800 Remanufactured: … 2 Aug-23-2012 Beckman Coulter Inc. UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical Systems, Part Numbers: DxC 660i: A648… 2 Aug-23-2012 Beckman Coulter Inc.

Siemens ADVIA Centaur® Syphilis (SYPH) Assay , 200 ReadyPack Reference Number 10492493 Product… 2 Aug-20-2012 Siemens Healthcare Diagnostics, Inc Alere Triage Tox+MTD Drug Screen, PN 94400 Product Usage: The Alere Triage TOX Drug Screen is a … 2 Jul-19-2012 Alere San Diego, Inc. Presage ST2 Assay, catalog numbers BC-1065 and BC-1065E. The Critical Diagnostics Presage ST2 Ass… 3 Jul-13-2012 Critical Diagnostics ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (4 x 100 tests), 2K91-25… 2 Jun-29-2012 Abbott Laboratories Brand Name: QuietCare, Model Numbers QC200403, v.02; QC200403, v.03; QC200403, v.04 — Classificatio…

3 Jun-05-2012 Intel-GE Care Innovations LLC VITROS 5600 Integrated System Software Version 1.6 & Below Product Usage: For use in the in vi… 2 Jun-01-2012 Ortho-Clinical Diagnostics Product is labeled in part: “***is immunosimplicity***ENA-6 Screen***Enzyme Immunoassay Test Kit***… 2 May-21-2012 Diamedix Corporation HemaSyst, Dual Cannula Tip with Adapter 16 ga. x 4” (10.2 cm). Product is labeled in part:”***Pouch … 2 May-11-2012 Haemacure Corporation ARCHITECT STAT Troponin-I Reagent Kit; list numbers 2K41-28 (500 test kit); an in-vitro diagnostic t… 2 May-10-2012 Abbott Laboratories Product is labeled in part: “***is immunosimplicity***HSV 1&2 IgM***Enzyme Immunoassay Test Kit***F…

3 May-10-2012 Diamedix Corporation AtheNA Multi-Lyte MMV Test System- A93111G A microparticle-based immunoassay intended for the qua… 3 May-08-2012 Zeus Scientific, Inc. VITROS® 5,1 FS Refurbished System, Product Codes: 6801375 &… 2 Apr-26-2012 Ortho-Clinical Diagnostics VITROS® 3600 Immunodiagnostic System Product Usage: For use in the in vi… 2 Apr-26-2012 Ortho-Clinical Diagnostics VITROS® 5,1 FS System, Product Codes: 6801375 & 680… 2 Apr-26-2012 Ortho-Clinical Diagnostics VITROS® 5600 Chemistry System, Product Code: 6802413 Product Usage: Fo… 2 Apr-26-2012 Ortho-Clinical Diagnostics VITROS® 4600 Chemistry System, Product Code: 6802445 Product Usage: Fo…

2 Apr-26-2012 Ortho-Clinical Diagnostics Siemens Healthcare Diagnostics Dimension Vista(R) software version 3.4 The Dimension Vista(R) Sys… 2 Apr-25-2012 Siemens Healthcare Diagnostics, Inc. Triage TOX Drug Screen (MTD) Panel, Model # 94400. Type of Packaging: 25 individually pouched devic… 2 Apr-20-2012 Alere San Diego dba Biosite Innovacon Hemosense Inc Elecsys Troponin I Immunoassay For the in-vitro quantitative determination of cardiac troponin I … 1 Apr-11-2012 Roche Diagnostics Operations, Inc. Elecsys Troponin I STAT Immunoassay For the in-vitro quantitative determination of cardiac tropon…

1 Apr-11-2012 Roche Diagnostics Operations, Inc. Access Immunoassay Systems Assay Protocol File (APF) Software versions for Access. Part Number: A… 2 Apr-06-2012 Beckman Coulter Inc. Access Immunoassay Systems Assay Protocol File (APF) Software versions for UniCel DxC 600i Systems. … 2 Apr-06-2012 Beckman Coulter Inc.

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