Events

Recall of Device Recall MULTIGENT Acetaminophen for use with Architect/Aeroset

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

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
    62017
  • Event Risk Class
    Class 2
  • Event Number
    Z-1902-2012
  • Event Initiated Date
    2012-05-29
  • Event Date Posted
    2012-06-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-11-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109698
  • 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
    Colorimetry, acetaminophen - Product Code LDP
  • Reason
    Discoloration of the acetaminophen enzyme reagent (r1), generates a high calibration factor and erratic control recovery.
  • Action
    Sekisui Diagnostics Llc sent an "IMPORTANT PRODUCT FIELD CORRECTION" letter dated May 29, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to immediately stop using the affected product and to destroy any remaining inventory. A Confirmation of Notification Form was attached for customers to complete and return via fax to 902-628-6504. Contact the firm at 902-628-0984 for questions regarding this notice.

Device

Device Recall MULTIGENT Acetaminophen for use with Architect/Aeroset
  • Model / Serial
    Lot 41928UQ11 {exp 2013-01 -31 )
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Illinois
  • Product Description
    MULTIGENT Acetaminophen for use with Architect/Aeroset || Cat. No. 2K99-20. || Assay is intended for the quantitative determination of acetaminophen in human serum or plasma.
  • Manufacturer
    Sekisui Diagnostics Llc

Manufacturer

Sekisui Diagnostics Llc
  • Manufacturer Address
    Sekisui Diagnostics Llc, 31 New York Ave, Framingham MA 01701-8860
  • Manufacturer Parent Company (2017)
    Sekisui Chemical Co. Ltd.
  • Source
    USFDA