Events

Recall of Device Recall XSYSTEMS Multiconstituent Controls for Abused Drug Assays

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

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
    32540
  • Event Risk Class
    Class 3
  • Event Number
    Z-1539-05
  • Event Initiated Date
    2005-06-27
  • Event Date Posted
    2005-09-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-01-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40299
  • 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
    Drug Mixture Control Materials - Product Code DIF
  • Reason
    The xsystems multiconstituent controls accessory insert (commodity number 34-3067/r6) does not contain the correct control ranges for the axsym opiates assay.
  • Action
    On 6/27/05, Abbott sent the customer letter via FedEx to all XSYSTEMS Multiconstituent Controls customers that received List Number 9687-12 lots 17270M100 and/or 18177M300 and/or AxSYM Opiates reagents (List Number 3B25-20) since June 01, 2004. The letters explained that the multiconstituent control ranges for morphine were not updated in the MCC Accesory insert at the same time they were updated in the AxSYM Opiates reagent package insert in 2004. The accounts were requested to review their current control ranges for the AxSYM Opiates assay, and verify that they are using either the control ranges in the AxSYM Opiates reagent package insert or control ranges established by their facility. They were also instructed to follow their facility''s normal policies and procedures for communicating with health care providers served by their laboratory. The accounts were requested to complete and return the enclosed reply sheet acknowledging the receipt of the letter and the dissemination of the letter to the laboratory manager/supervisor responsible for the assays.

Device

Device Recall XSYSTEMS Multiconstituent Controls for Abused Drug Assays
  • Model / Serial
    lot numbers 17270M100 and 18177M300
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide, including Puerto Rico, and internationally to Argentina, Australia, Barbados, Bermuda, Brazil, Canada, Cayman Island, Chile, China/Hong Kong, Columbia, Costa Rica, Dominican Republic, Ecuador, Guatemala, Germany, Honduras, Jamaica, Korea, Mexico, New Zealand, Panama, Peru, Singapore, St. Vincent, Thailand, Trinidad and Taiwan
  • Product Description
    XSYSTEMS AxSYM Multiconstituent Controls for Abused Drug Assays, list 9687-12; Abbott laboratories, Abbott Park, IL 60064 USA
  • Manufacturer
    Abbott Laboratories MPG

Manufacturer

Abbott Laboratories MPG
  • Manufacturer Address
    Abbott Laboratories MPG, 100 Abbott Park Rd, Abbott Park IL 60064-3502
  • Source
    USFDA