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    Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System; Model Number/Catalog Number: AS4010B; The product is manufactured by: BioGenex Laboratories, Inc. 4600 Norris Canyon Road San Ramon, CA 94583 and Distributed by: Abbott Molecular, 1300 E. Touhy Ave - 2E, Des Plaines, IL 60018 Xmatrx Automated Staining System is intended for in vitro diagnostic use. It is suitable for fluorescent hybridization (FISH) applications.

    FDA Recall
    Terminated ·Biogenex Laboratories·Product code KEY·January 23, 2009

    Shanghai International Holding Corp. GmbH(Europe)

    Authorized representative
    🇩🇪 Germany·637 Manufacturers·33064 Devices

    Glucose Oxidase Reagent as follows: Pointe Scientific Glucose Oxidase Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # G7519-1L, G7519-500 and G7519-SAM. 2MM Diagnostics Glucose Oxidase Reagent Set, 2MM Corporation, Miami, FL; Reorder # RT-160-500. Pointe Scientific Glucose Oxidase Reagent, Pointe Scientific, Inc., Canton, MI; Catalog, MI; Catalog # 2-G7519-L, 7-G7519-100, 7-G7519-200, 7-G7519-1000, 8-G7519-100, and 12-RT-160-500. For the quantitative determination of Glucose in human serum. For in vitro diagnostic use only.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code CGA·November 3, 2008

    Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.The OVAR test has not yet been cleared by the FDA, and until then can only be used as an investigational device.

    FDA Enforcement
    Class II ·Terminated·Neuro Kinetics, Inc.·September 9, 2015

    Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 504 ml, Catalog no. HA926-504, in vitro diagnostic, Pointe Scientific, Inc.; Canton, MI 48188

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code CKA·December 14, 2007

    Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 450 ml, Catalog no. A7526-450, in vitro diagnostic, Pointe Scientific, Inc.; Canton, MI 48188

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code CKA·December 14, 2007

    Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 610 ml, Catalog no. HA926-610, in vitro diagnostic, Pointe Scientific, Inc.; Canton, MI 48188

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code CKA·December 14, 2007

    Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 150 ml, Catalog no. A7526-150, in vitro diagnostic, Pointe Scientific, Inc.; Canton, MI 48188

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code CKA·December 14, 2007

    Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 625 ml, Catalog no. A7526-625, in vitro diagnostic, Pointe Scientific, Inc.; Canton, MI 48188

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code CKA·December 14, 2007

    Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 305 ml, Catalog no. HA 726-305, in vitro diagnostic, Pointe Scientific, Inc.; Canton, MI 48188

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code CKA·December 14, 2007

    Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 120 ml, Catalog no. 8-A7526-R1-120, in vitro diagnostic, Pointe Scientific, Inc.; Canton, MI 48188

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code CKA·December 14, 2007

    Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 120 ml, Catalog no. 7-A7526-R1-120, in vitro diagnostic, Pointe Scientific, Inc.; Canton, MI 48188.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code CKA·December 14, 2007

    Pointe Scientific Liquid Uric Acid (R1) Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog # HU482-R1. For the quantitative determination of uric acid in serum on Hitachi analyzers. For in-vitro diagnostic use only.

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

    Pointe Scientific Uric Acid (Liquid) Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog # HU782-246 and HU982-615. For the quantitative determination of uric acid in serum on Hitachi analyzers. For in-vitro diagnostic use only.

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

    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

    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

    Pointe Scientific Liquid Auto HDL Cholesterol Reagent Set, Pointe Scientific, Inc., Canton, MI, Catalog Numbers: 10-H7545-80, 12-H7545-162, 3-H7545-L, 7-H7545-1000, 7-H7545-320, 7-H7545-40, 7-H7545-80, H7545-1000, H7545-320, H7545-40, H7545-80, HH945-240, and HH945-480. The product is used for In vitro diagnostic for the quantitative determination of high-density lipoprotein cholesterol in human serum or plasma.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code LBR·January 29, 2009

    Pointe Scientific Liquid Auto HDL Cholesterol Reagent Set, Pointe Scientific, Inc., Canton, MI, Catalog Numbers: 10-H7545-80, 12-H7545-162, 3-H7545-L, 7-H7545-1000, 7-H7545-320, 7-H7545-40, 7-H7545-80, H7545-1000, H7545-320, H7545-40, H7545-80, HH945-240 and HH945-480. The product is used for In vitro diagnostic for the quantitative determination of high-density lipoprotein cholesterol in human serum or plasma.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code LBR·January 29, 2009

    MDSS GmbH

    Authorized representative
    🇩🇪 Germany·388 Manufacturers·16562 Devices