Events

Recall of ARCHITECT STAT Myoglobin Calibrators

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
    33845
  • Event Risk Class
    Class 3
  • Event Number
    Z-0400-06
  • Event Initiated Date
    2005-10-17
  • Event Date Posted
    2006-01-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-05-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42539
  • 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
    Myoglobin, Antigen, Antiserum, Control - Product Code DDR
  • Reason
    Some of the kits were shipped at the incorrect shipping temperature. they were shipped ambient, but should have been shipped frozen.
  • Action
    Abbott telephoned the laboratory end users on 10/17/05, informing them that Abbott discovered that ARCHITECT STAT Myoglobin Calibrators, lot V96128, were shipped to their facilities using the incorrect shipping conditions between August 29th and September 20th 2005. The kits should have been shipped frozen, but were shipped ambient. The error has been corrected. All shipments made after September 21, 2005 have been shipped correctly. Any data generated to date using this kit of calibrators is acceptable, providing that a valid calibration was achieved and product labeling was followed. However, long term use of this kit may result in calibration failures or controls out of range. The accounts were requested to mark the kit(s) of this lot currently in inventory to distinguish them from the replacement kit(s) Abbott will be sending to them. As a precaution, Abbott requested the labs to discontinue use of these kits and destroy them the replacement kits are received.

Device

ARCHITECT STAT Myoglobin Calibrators
  • Model / Serial
    list 02K43-01, lot number V96128
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Texas, Washington, Montana, Pennsylvania and Kentucky, and internationally to Korea
  • Product Description
    ARCHITECT STAT Myoglobin Calibrators; list 02K43-01; each kit contains 6 bottles of calibrators ranging from 0 ng/mL to 1200 ng/mL; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
  • Manufacturer
    Abbott Laboratories MPG

Manufacturer

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