Events

Recall of Liquid Stable 2Part Homocysteine Reagent

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtest Holdings, 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
    74234
  • Event Risk Class
    Class 2
  • Event Number
    Z-2063-2016
  • Event Initiated Date
    2015-04-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-07-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146910
  • 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
    Urinary homocystine (nonquantitative) test system - Product Code LPS
  • Reason
    Deterioration in performance of the liquid stable (ls) 2-part homocysteine reagent resulting in under recovery. the manufacturer has indicated that the homocysteine reagent lot listed above shows deterioration in assay performance manifesting itself by under recovery of homocysteine in controls and patient samples. the cause of this deterioration has been attributed to a loss of reductant activity in reagent 1. testing performed indicated that the affected lot is at the limit of acceptable clinical performance. this observation was consistent across the reportable range of the assay. for this reason, do not continue to use affected reagent lot. test data generated to date will be acceptable where validity control specifications have been met.
  • Action
    On 4/3/2015, Urgent Field Safety Notice notifications were sent to the affected customers via email with instructions for identifying and destroying the affected product. 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.

Device

Liquid Stable 2Part Homocysteine Reagent
  • Model / Serial
    Model: H7575-57 Lot: 416703 Expiration date: 2016-01
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    MI, MN, NJ, IL, NY. US Only.
  • Product Description
    Liquid stable 2 part Homocysteine Reagent, for in vitro quantitative determination of total homocysteine in human serum and plasma - H7575-57 kit includes one Rl and one R2 bottle and one bottle of calibrator level 1 and one bottle of calibrator level 2.
  • Manufacturer
    Medtest Holdings, Inc.

Manufacturer

Medtest Holdings, Inc.
  • Manufacturer Address
    Medtest Holdings, Inc., 5449 Research Dr, Canton MI 48188-2261
  • Manufacturer Parent Company (2017)
    Medtest Holdings Inc
  • Source
    USFDA