Events

Recall of Device Recall Pointe Scientific Creatinine Reagent

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
    71974
  • Event Risk Class
    Class 3
  • Event Number
    Z-2773-2015
  • Event Initiated Date
    2014-12-12
  • Event Date Posted
    2015-09-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-10-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139476
  • 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
    Creatinine kit c7539-150 contains creatinine reagent r1 that is labeled as creatinine reagent r2 (30ml) and reagent r2 vial is labeled as r1 (120ml). with manual procedure, no result will be reported as the control will be out of specifications.
  • Action
    On 12/12/2014, Field Correction Notice notifications were sent to the affected distributors via electronic mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Any questions concerning the corrective action may be directed to Pointe Scientifics Technical Service Department at 1-800-757-5313.

Device

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.

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