BEUDAMED
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    SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG and IgM assays that require sample predilution.

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories Ltd.·January 2, 2019

    MEDRAD Sterile Disposable Syringe Kit Recall, Catalog Number 150-FT-Q; Kit includes angiographic injector and syringe The contents of the package are intended to be used in the delivery of contrast media.

    FDA Recall
    Terminated ·Medrad Inc·Product code DXT·May 17, 2010

    Synchron Phenobarbital (PHE) Reagent, P/N 469785, Classification Product Code: KLT. Subsequent Product Codes: DIP, KLS, LCD, LCQ, LCR, LFN. PHE reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems Drug Calibrator 1, is intended for quantitative determination of Phenobarbital concentration in human serum or plasma.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code DKB·August 11, 2009

    Synchron Phenobarbital (PHE) Drug Calibrator 1, P/N 469600, Classification Product Code: KLT. Subsequent Product Codes: DIP, KLS, LCD, LCQ, LCR, LFN. The Beckman Coulter SYNCHRON Systems DRUG CALIBRATOR 1, when used in conjunction with SYNCHRON reagents, is intended for use on the SYNCHRON Systems for the calibration of Carbamazepine, Phenobarbital, Phenytoin, Theophylline, and Valproic Acid.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code DLZ·August 11, 2009

    Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05055273204032 Product Usage: Liquid Protein Calibrators are intended for in vitro diagnostic use in the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgA, IgG, IgM, Prealbumin, and Transferrin assays on Clinical Chemistry and Immunoassay systems, Abbott Spectrum, Abbott Aeroset, Abbott Architect i2000, Architect i2000sr, Ace analyser, Bayer Advia 1650, Advia 2400, Advia 1200, Dade Dimension RXL, Dimension AR, Hitachi 704, Hitachi 717, Hitachi 911, Hitachi 917, Hitachi 912, Hitachi 747, Kone progress, AU800, AU600, AU400, AU2700, AU5400, Selectra Vitalab, Synchron CX4, Synchron CX5, Synchron CX7, Synchron LX20, ILAB300, ILAB900, ILAB1800, ILAB600, RX Daytona, RX Imola, Cobas Mira, Cobas Mira S, Cobas Mira Plus systems

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories Ltd.·November 13, 2019

    Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States).

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTQ·August 1, 2005

    Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTQ·August 1, 2005

    Terumo Advanced Perfusion System 1- 4" Roller Pump for Terumo System 1 Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTQ·November 10, 2011

    Perfusion System 8000, base 5 pump, 115V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTQ·September 25, 2012

    Perfusion System 8000, base 4 pump, 220V/240V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTQ·September 25, 2012

    Perfusion System 8000, base 5 pump, 220V/240V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTQ·September 25, 2012

    Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States).

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTQ·October 16, 2006

    Terumo Advanced Perfusion System 1 Level Detection; Catalog number 802111.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTQ·October 12, 2004

    Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTQ·October 6, 2005

    Terumo Advanced Perfusion System 1 Roller Pump; 4 inch diameter; Catalog number 801040.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTQ·October 16, 2003

    Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTQ·April 1, 2004

    Terumo Perfusion System 8000 Roller Pump, 220/240V; Model 8000; Catalog No. 16407.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTQ·July 1, 2004

    Terumo Perfusion System 8000 Roller Pump, 1040V; Model 8000; Catalog No. 16411. (Not distributed within the United States).

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTQ·July 1, 2004

    Jostra HL-20 Heart Lung Machine - guiding pins

    FDA Recall
    Terminated ·MAQUET Inc.·Product code DTQ·October 3, 2006

    DIFCO Laboratories, FA Streptococcus Group A, 5mL, Catalog Number: 223181, Lot number: 6122656, Exp: 20090705, in vitro diagnostic.

    FDA Recall
    Terminated ·BD Diagnostic Systems Lee Laboratories·Product code GTQ·August 8, 2007