Events

Recall of Device Recall DRI Salicylate Serum Tox Assay

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Microgenics Corporation.

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
    74861
  • Event Risk Class
    Class 2
  • Event Number
    Z-2884-2016
  • Event Initiated Date
    2016-07-25
  • Event Date Posted
    2016-09-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-11-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148620
  • 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
    Colorimetry, salicylate - Product Code DKJ
  • Reason
    Some lots of dri salicylate serum tox assay negative patient samples are recovering higher than the product sensitivity claim of 4.4 mg/dl.
  • Action
    The firm, Thermo Fisher Scientific, sent an "URGENT MEDICAL DEVICE FIELD ACTION" letter dated July 25, 2016 by regular mail to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to determine if they are using or have inventory of any of the affected lots; discontinue use and destroy any remaining inventory of affected lots per local wastes ordinances; retain a copy of the letter for laboratory records; if you have forwarded kits of the affected lots, provide a copy of letter to them; and complete and return attached Medical Device Field Action Response Form within 5 days to Thermo Fisher Scientific Technical Service via fax at 1-888-527-8001 (USA toll free), 510-979-5420 (outside of USA) or email to techservice.mgc@thermofisher.com. If you have any questions contact Technical Services at 1-800-232-3342 (USA only) or 510-969-5000 (outside the USA) press option 2 then option 3.

Device

Device Recall DRI Salicylate Serum Tox Assay
  • Model / Serial
    Lot Number Expiration Date 60704602 DEC 2016; 72035410 JUL 2017; 72208738 FEB 2018; 72409454 OCT 2018.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) to states of: AZ, CA, MO, TX, and PR and countries of: Canada, Germany, Hong Kong, Italy, Malaysia, and Taiwan.
  • Product Description
    DRI Salicylate Serum Tox Assay, Catalog number 0977. || Toxicology: || The DRI Salicylate Serum Tox Assay is intended for the quantitative determination of salicylate in human serum or plasma.
  • Manufacturer
    Microgenics Corporation

Manufacturer

Microgenics Corporation
  • Manufacturer Address
    Microgenics Corporation, 46500 Kato Rd, Fremont CA 94538-7310
  • Manufacturer Parent Company (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA