Events

Recall of Device Recall Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems

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
    65187
  • Event Risk Class
    Class 2
  • Event Number
    Z-1563-2013
  • Event Initiated Date
    2013-05-13
  • Event Date Posted
    2013-06-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-08-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118166
  • 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
    Single (specified) analyte controls (assayed and unassayed) - Product Code JJX
  • Reason
    It has been confirmed from in-house testing that direct bilirubin (dbil), and total bilirubin (tbil) claimed in thermo scientific mas bilirubin systems are displaying reduced stability.
  • Action
    ThermoFisher Scientific sent a Product Recall Notification letter dated May 13, 2013, by Certified US mail to all affected customer. The letter identified the product the problem and the action needed to be taken by the customers. Customers were instructed 1. Determine if you are using or have inventory of the recalled product. 2. Discontinue use of the product immediately. 3. Evaluate quality controls. They may vary among laboratories and should be evaluated according to laboratory procedures. 4. Retain a copy of the letter for laboratory records. 5. If any of the affected lots of MAS Bilirubin had been forwarded to another laboratory, please provide a copy of the recall letter to them. 6. Complete and return the response form within 5 days. Letters also provide an alternative product - MAS Bilirubin part number BC103. Questions or concerns may be directed to Technical Services at 1-800-232-3342 or 510-979-5417.

Device

Device Recall Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems
  • Model / Serial
    Catalog Number: 10014432;  Lot Numbers:  1MQ310, Expiration Date: 31 Dec 2013, 2CQ310, Expiration Date: 31 Mar 2014, 2KQ310, Expiration Date: 31 Oct 2014
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution: US including the states of WI, UT, FL NY, PA, IL, CO, AZ and NJ.
  • Product Description
    Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Product is manufactured and distributed by Microgenics Corporation, Fremont, CA || MAS Bilirubin is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Includes Bilirubin with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
  • 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