Events

Recall of Device Recall Multigent Vancomycin Calibrators

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

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
    60233
  • Event Risk Class
    Class 2
  • Event Number
    Z-0297-2012
  • Event Initiated Date
    2011-06-08
  • Event Date Posted
    2011-11-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104837
  • 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
    Calibrators, drug specific - Product Code DLJ
  • Reason
    Complaint from the sole distributor that the third party control material is recovering high, and outside the published range.
  • Action
    Microgenics sent a Product Removal notification letter dated June 15, 2011 to all affected customers. The letter identified the affected product, the problem, and the necessary actions to be taken. Customers were instructed to discontinue use and dispose of the affected product per local waste ordinances, review all patient results reported with the use of this lot, and retain a copy of this notification for their records. The letter states that if the affected product has been forwarded to another laboratory, a copy of the letter is to be provided to them. An alternative calibrator is available to customers impacted. It can be ordered by calling Thermo Fischer Scientific Customer Service at 1-800-232-3342. Questions regarding the information should be forwarded to Abbott Customer Service at 1-877-4ABBOTT.

Device

Device Recall Multigent Vancomycin Calibrators
  • Model / Serial
    Catalog number: 6E44-01; Lot 59446762, Exp 3/31/12; lot 59391741, Exp 12/31/2011.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution (USA) in the state of ILLINOIS
  • Product Description
    Multigent Vancomycin Calibrators; || Manufactured by Microgenics Corp, Fremont, CA. || Distributed by: Abbott Diagnostics, Abbott Park, IL || Product Usage: || The Multigent Vancomycin calibrators are intended for use in the calibration of the multiagent vancomycin || Vancomycin is a commonly used antibiotic to treat staphylococcus and other gram-positive bacterial infections.
  • Manufacturer
    Microgenics Corp

Manufacturer

Microgenics Corp
  • Manufacturer Address
    Microgenics Corp, 46360 Fremont Blvd, Fremont CA 94538
  • Manufacturer Parent Company (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA