Events

Recall of Device Recall ARCHITECT B12 Reagents

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

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
    29911
  • Event Risk Class
    Class 3
  • Event Number
    Z-1452-04
  • Event Initiated Date
    2004-08-19
  • Event Date Posted
    2004-09-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-07-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34759
  • 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
    Radioassay, Intrinsic Factor Blocking Antibody - Product Code LIG
  • Reason
    Changes in the architect b12 reagent lots may adversely affect the shape of the calibration curve, over time. these changes may produce controls out of range low and similar decreases in patient sample values prior to current expiration of the reagents.
  • Action
    Abbott affiliates in Canada, Germany, Singapore, Hong Kong, Australia, New Zealand and Japan were e-mailed copies of the recall letter on 8/19/04 for translation where needed and dissemination to their accounts receiving the suspect lots. The end users were advised of the potential for changes in the reagents over time that affect the shape of the calibration curve, producing controls out of range low and similar decreases in patient sample values. The accounts were instructed to manually update the expiration dates for the reagent lots according to the chart given in the recall letter for any of the affected lots remaining in inventory. The expiration date reported by the Architect instrument must also be manually updated.

Device

Device Recall ARCHITECT B12 Reagents
  • Model / Serial
    List 6C09-20, lots 11002M300, 11003M300, 16051M200, 18288M300; List 6C09-25, lots 11002M301, 16051M201, 18288M301
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Canada, Germany, Singapore, Hong Kong, Australia, New Zealand and Japan.
  • Product Description
    ARCHITECT B12 Reagents, List 6C09-20 (4 x 100 tests) and List 6C09-25 (100 tests); Abbott Laboratories, Abbott Park, IL 60064 USA; Abbott, Max-Planck-Ring 2, 65205 Wiesbaden, Germany
  • Manufacturer
    Abbott Laboratories HPD/ADD/GPRD

Manufacturer

Abbott Laboratories HPD/ADD/GPRD
  • Manufacturer Address
    Abbott Laboratories HPD/ADD/GPRD, 100 Abbott Park Rd, Abbott Park IL 60064-3502
  • Source
    USFDA