Events

Recall of Device Recall Pointe Scientific Creatinine Reagent R2

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Pointe Scientific, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    54094
  • Event Risk Class
    Class 2
  • Event Number
    Z-1036-2010
  • Event Initiated Date
    2009-12-01
  • Event Date Posted
    2010-03-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87473
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Alkaline Picrate, Colorimetry, Creatinine - Product Code CGX
  • Reason
    An additional 10% picric acid was added to the r2 component during production.
  • Action
    Consignees were notified by An Urgent: Medical Device Recall letter, dated 12/1/09, that identified the affected product. Customers were asked to immediately examine their inventory for the affected product and to notify any customers that the product may have been further distributed to by giving them a copy of the recall notice. Customers are to dispose of the affected product immediately. Questions should be directed to the Technical Support Department at (800)757-5313 or (734)487-8300. There is also a Recall Response form attached with this notice.

Device

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.

Manufacturer

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