Events

Recall of Device Recall ThermoFisher/Microgenics

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
    60756
  • Event Risk Class
    Class 2
  • Event Number
    Z-0637-2012
  • Event Initiated Date
    2011-12-14
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-10-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106402
  • 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
    Cardiac marker In Vitro Diagnostic - Product Code JJY
  • Reason
    Low measurements of troponin i in the mas cardioimmune xl control which were outside the published control ranges.
  • Action
    On 12/14/2011, ThermoFisher Scientific issued letters via express mail to all its direct consignees, informing them of the affected products and providing instructions on the recall.

Device

Device Recall ThermoFisher/Microgenics
  • Model / Serial
    Catalog number, Lot Numbers & Expiration Dates: CAI-XLL, CXL1301L, 31 JAN 2013;  CAI-XL1, CXL13011, 31 JAN 2013;  CAI-XL2, CXL13012, 31 JAN 2013;  CAI-XL3, CXL13013, 31 JAN 2013;  CAI-XL4, CXL13014, 31 JAN 2013;  CAI-XLS, CXL1301S, 31 JAN 2013
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and Worldwide, including Germany, France, Italy and Spain.
  • Product Description
    ThermoFisher Scientific / Microgenics brand MAS CardioImmune XL, Liquid Assayed Cardiac Marker Control, in vitro diagnostic. || Catalog Numbers & Description: || CAI-XLL, Level L; CAI-XL1, Level 1; CAI-XL2, Level 2; CAI-XL3, Level 3; || CAI-XL4, Multi-Pack; CAI-XLS, Sample Pack;
  • Manufacturer
    Microgenics Corporation

Manufacturer

Microgenics Corporation
  • Manufacturer Address
    Microgenics Corporation, 44660 Osgood Rd, Fremont CA 94539-6410
  • Manufacturer Parent Company (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA