Events

Recall of Device Recall Pointe Scientific Direct Bilirubin Reagent Set

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
    52851
  • Event Risk Class
    Class 2
  • Event Number
    Z-1014-2010
  • Event Initiated Date
    2009-07-29
  • Event Date Posted
    2010-03-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84124
  • 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
    Diazo colorimetry, bilirubin - Product Code CIG
  • Reason
    R2 reagent component may fail because it may contain r1 reagent. the reagent was rendered inoperative and would not pass the required quality control (calibration and quality control testing) before beginning running the bilirubin assay.
  • Action
    Consignee was notified by letter dated 7/29/2009 and instructed to identify and notify them at once of this product recall. Product is to be returned or destroyed. Customers with questions should contact the firm directly.

Device

Device Recall Pointe Scientific Direct Bilirubin Reagent Set

Manufacturer

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