Events

Recall of Device Recall RF IgA Calibrator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Thera Test Laboratories, 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
    61500
  • Event Risk Class
    Class 2
  • Event Number
    Z-1546-2012
  • Event Initiated Date
    2012-03-29
  • Event Date Posted
    2012-05-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-09-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108288
  • 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
    System, test, rheumatoid factor - Product Code DHR
  • Reason
    The rf iga calibrator component of the el-rf/3 rheumatoid factor test system may be unstable, resulting in a drop in the rf iga calibrator od value which could invalidate an rf iga test run.
  • Action
    TheraTest sent "Urgent Device Recall" letters dated March 28, 2012 to customers that received the affected kit, requesting them to return or destroy the remainder of the product. TheraTest issued a replacement kit to all customers that had unused product as well as any material they consumed which resulted in a failed run. Customers were also instructed to complete the enclosed confirmation form and fax the completed form back to TheraTest. Any questions were directed to TheraTest at 800-441-0771.

Device

Device Recall RF IgA Calibrator
  • Model / Serial
    RF IgA Calibrator: component catalog number 12833, lot number 11118586, exp. 28 DEC 2012; EL-RF/3: kit catalog number 303-305, lot number 11118583, exp. 28 NOV 2012.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution (US)
  • Product Description
    RF IgA Calibrator, a component of the EL-RF/3 Rheumatoid Factor Test Kit; an in vitro diagnostic; TheraTest Laboratories, Lombard, IL 60148; component catalog #12833, kit catalog #303-305. The TheraTest EL-RF/3 is intended as an aid to the diagnosis of Rheumatoid Arthritis (RA).
  • Manufacturer
    Thera Test Laboratories, Inc.

Manufacturer

Thera Test Laboratories, Inc.
  • Manufacturer Address
    Thera Test Laboratories, Inc., 1111 N Main St, Lombard IL 60148-1360
  • Source
    USFDA