Events

Recall of Device Recall Architect Sirolimus Reagent Pack

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

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
    55871
  • Event Risk Class
    Class 2
  • Event Number
    Z-2172-2010
  • Event Initiated Date
    2010-05-27
  • Event Date Posted
    2010-08-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-07-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92107
  • 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
    Sirolimus test system - Product Code NRP
  • Reason
    The architect sirolimus assay lot 80162m100 is exhibiting higher than normal reports of barcode read errors.
  • Action
    Abbott sent a "Product Recall" letter dated May 27, 2010, to all customers receiving the affected lot of reagent. The customers were informed of the increased frequency of barcode read errors due to the print quality of the barcode label. The following error codes have been observed for some kits within the lot: 4000 - Unable to read reagent bar code in position (x) on (y) carousel, 0208 - Reagent carousel scan error, and 2011 - Extra reagent bottle detected in position (x) on (y) carousel. The customers were requested to determine if they are currently using or have inventory of lot 80162M100, discontinue use of and destroy any remaining inventory of the lot, and retain a copy of the letter for their laboratory records. Customers requiring additional information were directed to contact Abbott Customer Service at 1-877-422-2688. Customers outside the U.S., please contact your local Customer Service representative.

Device

Device Recall Architect Sirolimus Reagent Pack
  • Model / Serial
    Lot 80162M100, Expiry Date May 03, 2011
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA including Puerto Rico, and countries of Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, New Zealand, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, Venezuela and Vietnam.
  • Product Description
    Architect Sirolimus Reagent Pack; 100 test pack containing 1 bottle (8.0 mL) Anti-Sirolimus Coated Microparticles, 1 bottle (8.0 mL) Sirolimus Acridinium-labeled Conjugate in Citrate Buffer, and 1 bottle (10 mL) Assay Diluent containing saline; Abbott Laboratories, Abbott Diagnostics Division, Abbott Park, IL 60064 USA; list 01L76-25. || The Architect Sirolimus assay is chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of sirolimus in human whole blood on the Architect i System, as an aid in the management of renal transplant patients receiving sirolimus therapy.
  • Manufacturer
    Abbott Laboratories

Manufacturer

Abbott Laboratories
  • Manufacturer Address
    Abbott Laboratories, 100 Abbott Park Rd, Abbott Park IL 60064-3502
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA