Events

Recall of Device Recall ARCHITECT Folate Reagent Kit

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
    31410
  • Event Risk Class
    Class 2
  • Event Number
    Z-0783-05
  • Event Initiated Date
    2005-03-11
  • Event Date Posted
    2005-04-28
  • 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=37825
  • 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
    Acid, Folic, Radioimmunoassay - Product Code CGN
  • Reason
    Concentrations for normal samples generated with current reagent lots of the architect folate assay are lower than data generated for the package insert.
  • Action
    Abbott international affilates were notified of the recall by e-mail on 03/11/2005, and requested to notifiy their customers. The letters inform the end users of the downward shift in control and/or patient results, and requested them to assess their normal and deficient ranges for their specific population, assess their quality control ranges and follow their laboratory procedures for reviewing patient results and notifying Health Care Providers that they serve. There was no U.S. distribution.

Device

Device Recall ARCHITECT Folate Reagent Kit
  • Model / Serial
    lot numbers 21082M200, 22024M100, 21082M201, 22024M101, 16603M200, and 22025M100
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Canada, Singapore, New Zealand, Germany, Hong Kong, Japan, and Australia
  • Product Description
    ARCHITECT Folate Reagent Kit, list 6C12-20 ( 4 x 100 tests), 6C12-25 (1 x 100 tests) and 6C12-30 (4 x 500 tests), Abbott Laboratories, Abbott Park, IL 600064 U.S.A.
  • Manufacturer
    Abbott Laboratories MPG

Manufacturer

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