BEUDAMED
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    Roche Diagnostics NAPA2, N-Acetyl-Procainamide, COBAS INTEGRA, Roche Diagnostics, Indianapolis, IN.; 20737852322. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the qualitative determination of NAPA in serum or plasma.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code CGX·June 11, 2008

    SYNCHRON Systems Modular Creatinine (CREm) Reagent Kit, Part Number: 472525 Systems AQUA CAL 1 and 2, is intended for the quantitative determination of creatinine concentration in human serum, plasma or urine. CREm reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 800 System and SYNCHRON Systems AQUA CAL 1 and 2, is intended for the quantitative determination of creatinine concentration in human serum, plasma or urine.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CGX·August 2, 2010

    Pointe Scientific Creatinine Reagent R2, Pointe Scientific, Inc., Canton, MI; Catalog 3-C7539-L, 7-C7539-R2-30, 7-C7539-R2-125, 7-C7539-R2-250, 8-C7539-R2-30, 8-C7539-R2-125 and 8-7539-R2-250. For the quantitative determination of creatinine in serum. For in-vitro diagnostic use only.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code CGX·December 1, 2009

    Creatinine, Part Numbers OSR6178, OSR6678 Product Usage: System reagent for the quantitative determination of Creatinine in human serum and urine on Beckman Coulter AU analyzers.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CGX·December 28, 2012

    ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot Numbers: 203273706, 203273707, 203273808, 203273709. The ABX PENTRA Creatinine 120 CP is an in vitro diagnostic assay for the quantitative determination of creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffe method). It is composed of a 27 ml monoreagent cassette. Reagent is a chemical solution with additives. ABX PENTRA Creatinine 120 CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in vitro determination of Creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffe method). Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. This reagent is intended for use on the ABX PENTRA 400 Clinical Chemistry Analyzer.

    FDA Recall
    Terminated ·Horiba Instruments, Inc dba Horiba Medical·Product code CGX·September 14, 2012

    Creatinine/Endpoint [Modified Heinegard-Tiderstrom] for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.

    FDA Recall
    Terminated ·Sterling Diagnostics, Inc.·Product code CGX·July 20, 2016

    Pointe Scientific Creatinine Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog # C7539-150, C7539-625, C7539-625-S, C7539-1250, HC939-756, HC939-1340, 12-C7539-98, 8-C7539-R1-120, 8-C7539-R1-500, 8-C7539-R1-1000, 7-C7539-R1-120, 7-C7539-R1-1000, and 7-C7539-R1-500. For the quantitative determination of creatinine in serum. For in-vitro diagnostic use only.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code CGX·December 1, 2009

    Dimension(R) Creatinine Flex(R) Reagent Cartridges The CREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the Dimension Vista System.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CGX·December 27, 2010

    ABX PENTRA Enzymatic Creatinine CP ref. A11A01907 reagent is intended for the quantitative in vitro diagnostic determination of creatinine in human serum, plasma and urine based on an enzymatic method of using a multi-step approach ending with a photometric end-point reaction.

    FDA Recall
    Terminated ·Horiba Instruments Inc·Product code CGX·January 11, 2016

    Atellica CH Chemistry Calibrator

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CGX·June 5, 2020

    Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro diagnostic C7539-150 kit includes one R1 and one R2 bottle. R1: HDPE plastic bottle. 120 ml fill. R2: HDPE plastic bottle. 90 ml fill.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code CGX·December 12, 2014

    Dimension(R) Creatinine Flex(R) Reagent Cartridges. The CREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the Dimension Vista System.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CGX·November 22, 2011

    Abbott Clinical Chemistry AEROSET/ ARCHITECT c8000 Creatinine. List No. 7D64-20

    FDA Recall
    Terminated ·Abbott Laboratories Diagnostic Div·Product code CGX·July 27, 2004

    JAMSHIDI (TJ) NEEDLE BM ASP MAC [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 3.5, d.) 8G x 6, e.) 11G x 6]; STERILE;

    FDA Recall
    Terminated ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code FSH·February 23, 2017

    JAMSHIDI (TJ) NEEDLE BONE MARROW [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 4, d.) 8G x 6, e.) 11G x 6]; STERILE;

    FDA Recall
    Terminated ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code FSH·February 23, 2017

    JAMSHIDI (TJ) NEEDLE BM ASP MAC [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 3.5, d.) 8G x 6, e.) 11G x 6]; STERILE;

    FDA Enforcement
    Class II ·Terminated·Carefusion 2200 Inc·April 25, 2018

    JAMSHIDI (TJ) NEEDLE BONE MARROW [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 4, d.) 8G x 6, e.) 11G x 6]; STERILE;

    FDA Enforcement
    Class II ·Terminated·Carefusion 2200 Inc·April 25, 2018

    Monoject Bone Marrow Biopsy / Aspiration Tray with Safety Components 8G x 4 inch Product Number: 8881847084

    FDA Recall
    Terminated ·Kendall Healthcare Products Co·Product code FMI·October 8, 2004

    T-LOK BONE MARROW BIOPSY NEEDLE 8G x 4 EXT CAN; T-LOK BONE MARROW BIOPSY NEEDLE 11G x 4 EXT CAN Intended for the purpose of harvesting bone and/or bone marrow specimens

    FDA Enforcement
    Class II ·Terminated·Argon Medical Devices, Inc·February 22, 2017

    T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lok Bone Marrow Biopsy Needle 11G x 4 Ext Can, Part Number DBMNJ1104TL; Bone Marrow Biopsy Needle 13G x 4, Part Number DBMNJ1304

    FDA Enforcement
    Class II ·Terminated·Argon Medical Devices, Inc·July 29, 2015