Events

Recall of Device Recall Tobramycin 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
    60503
  • Event Risk Class
    Class 2
  • Event Number
    Z-0773-2012
  • Event Initiated Date
    2011-11-11
  • Event Date Posted
    2012-01-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105597
  • 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
    Reports that third party control material for 4 lots of tobramycin calibrators that are recovering low and outside of the published range.
  • Action
    ThermoFisher Scientific sent a product removal letter dated November 11, 2011. Letters were sent to the sole distributor of the product. The letter identified the product the problem and the action needed to be taken by the customer. If you are using or have inventory of the affected lot numbers immediately discontinue use and destroy any remaining affected lot numbers per your local waste ordinances. If you have any further questions regarding this information please call 1-877-4Abbott. Customers outside the US should contact their local customer service.

Device

Device Recall Tobramycin Calibrators
  • Model / Serial
    Lots:   59281991, Exp 11-30-11,  59359468, Exp 2-29-12,   59590335, Exp 6-30-12,   59511648, Exp 8-31-12.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- Nationwide Distribution including the country Europe.
  • Product Description
    Tobramycin Calibrators, REF 7F93-01; || Microgenics Corporation, 46360 Fremont Blvd Fremont, CA 94538; || Distributed by Abbott Diagnostics, 100 Abbott Park Road, Abbott Park, Illinois 60064. || .Tobramycin is a commonly used antibiotic to treat bacterial infections, in particular gram negative 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