Events

Recall of Gemcal Reference Serum (magnesium calibrator). Calibrator, Multianalyte Mixture. Level 1 and Level 2 Chemistry Control.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Alfa Wassermann, 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
    34687
  • Event Risk Class
    Class 2
  • Event Number
    Z-0676-06
  • Event Initiated Date
    2006-01-26
  • Event Date Posted
    2006-03-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-04-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44474
  • 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
    Calibrator, Multi-Analyte Mixture - Product Code JIX
  • Reason
    Inaccurate test results. the magnesium values for the a31/a41 gemcal serum calibrator gave control results that were biased approx. 20% high.
  • Action
    Field correction letters were sent to the firm's customers via FAX on 1/14/2006-1/17/2006 and via UPS on 1/17/2006-1/19/2006. An updated letter was sent out via FAX on 1/27,30,31/2006 and via UPS on 1/30/2006 and 2/1/2006.

Device

Gemcal Reference Serum (magnesium calibrator). Calibrator, Multianalyte Mixture. Level 1 and Le...
  • Model / Serial
    Catalog Number: S1-32: Lot:  A31, Exp. 2/2006 (Kit lot #F1458); A41, Exp. 1/2007 (Kit lot # F1757, F1757A, F1757B, and F1757C).
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The kits were sent nationwide. The product was shipped to Alfa Wasserman's sister firm in Wergen, Netherlands. There are several US Navy accounts.
  • Product Description
    Gemcal Reference Serum (magnesium calibrator). Calibrator, Multianalyte Mixture. Level 1 and Level 2 Chemistry Control.
  • Manufacturer
    Alfa Wassermann, Inc

Manufacturer

Alfa Wassermann, Inc
  • Manufacturer Address
    Alfa Wassermann, Inc, 4 Henderson Dr, West Caldwell NJ 07006-6608
  • Source
    USFDA