Events

Recall of Device Recall Pointe Scientific Liquid Hitachi Calcium 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
    53784
  • Event Risk Class
    Class 2
  • Event Number
    Z-1043-2010
  • Event Initiated Date
    2009-11-10
  • Event Date Posted
    2010-03-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86560
  • 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
    Calcium Reagent Set - Product Code CIC
  • Reason
    Non-compliance with the good manufacturing practice regulations, as the manufacturing process for this product had not been validated.
  • Action
    Consignees were notified by "Urgent: Medical Device Recall" letter dated November 11, 2009 and instructed to conduct a recall to the retail level, that users should dispose of the product immediately, and that a business reply card should be returned to account for products. If you have any questions, please call Pointe Scientific, Inc. Technical Support Department at 1-800-757-5313 or 1-734-487-8300.

Device

Device Recall Pointe Scientific Liquid Hitachi Calcium Reagent Set
  • Model / Serial
    All lots containing 813401 as part of the lot number.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution (United States, Chile, India, Republic of Yemen and Trinidad).
  • Product Description
    Calcium (CPC) R2 Reagent Set. Pointe Scientific Liquid Calcium (CPC) R2 Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s HC402-R2. Calcium CPC Hitachi Reagent Set for repackaging, Catalog # 3-HC902-R2. || The product is used for the quantitative determination of calcium in serum on Hitachi analyzers.
  • 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