Events

Recall of Device Recall DRI Cocaine Metabolite Assay, Multigent Cocaine Assay

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
    65883
  • Event Risk Class
    Class 2
  • Event Number
    Z-2267-2013
  • Event Initiated Date
    2013-07-23
  • Event Date Posted
    2013-09-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-12-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120699
  • 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
    Enzyme immunoassay, cocaine and cocaine metabolites - Product Code DIO
  • Reason
    Surveillance of reagent stability for specific lots of dri cocaine metabolite reagent show an unexpected decreasing change in the reaction rate, indicating a faster than expected reagent degradation.
  • Action
    Thermo Fisher Scientific sent an Urgent Medical Device Recall letters dated July 23, 2013, except Abbott labs who was mailed a letter on August 2, 2013. Abbott had previously been notified by telephone of the recall.The letter identified the product the problem and the action needed to be taken by the customer. Customers advised users on reagent stability issue with specific lots and the fact that it indicated a faster than expected degradation of the reagent. Microgenics asked that all use of the affected lots be stopped. Customers were informed that since each patient run is monitored with the controls at +/-25% of the cutoff, a possibility of reporting incorrect patient results is minimal to nonexistent. The use of appropriate controls addresses an risks of incorrect results. In addition to stopping use of the affected reagent, customers are asked to contact Thermo Fisher Scientific for replacement and to keep a copy of the recall letter for laboratory files. If the affected lots of reagent were forwarded to any other laboratories, they should be contacted immediately.. The enclosed acknowledgement form is to be completed and returned indicating that the letter was received, how much product, if any was on hand and destroyed. Questions and concerns may be addressed to Microgenics Technical Service at 1-800-232-3342 or 510-979-5417.

Device

Device Recall DRI Cocaine Metabolite Assay, Multigent Cocaine Assay
  • Model / Serial
    Part no. 0055, lot number 60053405, Exp 2/29/2016; Part No. 0056, lot number 60053396, Exp 2/29/2016; Part No. 10014593, lot number 60112588, Exp 2/29/2016; - not distributed Part number #l40-20, lot number 24215M500, Exp 8/13/14.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution including the states of DC, MA, NJ, TX. FL, CA, WA, NY, TX, CT, KY, LA, AR, TN, AL, GA, CT, VA, NC, KS, MD, OH and IL
  • Product Description
    DRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott Laboratories. || 100 ml, IVD || Mfg by: || Microgenics Corporation, || 46360 Fremont Blvd. || Fremont, CA 94538 || The DRI Cocaine Metabolite Enzyme Immunoassay is a homogeneous enzyme intended for the qualitative and semi-quantitative determination of benzoylecgonine (Cocaine Metabolite) in human urine with either 300 ng/mL or 150 ng/mL as a cutoff calibrator. The assay provided only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirm analytical result.
  • Manufacturer
    Microgenics Corp

Manufacturer

Microgenics Corp
  • Manufacturer Address
    Microgenics Corp, 46360 Fremont Blvd, Fremont CA 94538-6406
  • Manufacturer Parent Company (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA