Devices

Device Recall Pointe Scientific Creatinine Reagent

  • Model / Serial
    C7539-150 Lot: 406201 Batch: 279 Expiration date: 2016-03
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution. US nationwide, Singapore, Kenya, Bolivia, Mexico, Greece, Guyana, and Philippines.
  • Product Description
    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.
  • Manufacturer
    Pointe Scientific, Inc.
  • 1 Event

Manufacturer

Pointe Scientific, Inc.
  • Manufacturer Address
    Pointe Scientific, Inc., 5449 Research Dr, Canton MI 48188-2261
  • Manufacturer Parent Company (2017)
    Medtest Holdings Inc
  • Source
    USFDA

2 devices with a similar name

Learn more about the data here

Device Recall Pointe Scientific Creatinine Reagent Set
  • Model / Serial
    All lots numbers containing the numbers 923202; exp. 2011-08.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, Bolivia, Greece, Guyana, India, Indonesia, Israel, Kenya, Korea, Malaysia, Mexico, Pakistan, Philippines, Russia, Serbia, Sri Lanka, Tanzania, Trinidad and Ukraine.
  • Product Description
    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.
  • Manufacturer
    Pointe Scientific, Inc.
Device Recall Pointe Scientific Creatinine Reagent R2
  • Model / Serial
    All lots numbers containing the numbers 923202; exp. 2011-08.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, Bolivia, Greece, Guyana, India, Indonesia, Israel, Kenya, Korea, Malaysia, Mexico, Pakistan, Philippines, Russia, Serbia, Sri Lanka, Tanzania, Trinidad and Ukraine.
  • Product Description
    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.
  • Manufacturer
    Pointe Scientific, Inc.