Events

Recall of Device Recall Spectrolyse PAI1

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
    63016
  • Event Risk Class
    Class 2
  • Event Number
    Z-2431-2012
  • Event Initiated Date
    2012-08-28
  • Event Date Posted
    2012-09-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-07-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112279
  • 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
    Test, qualitative and quantitative factor deficiency - Product Code GGP
  • Reason
    Spectrolyse pai-1 activity assay producing lower than expected absorbance values with "0" standard. this will reduce the slope of the standard curve requiring the user to make more frequent sample dilutions.
  • Action
    The firm, Sekisui Diagnostics, LLC, sent an "URGENT PRODUCTS RECALL NOTICE" dated August 28, 2012 to its customers. The notice describes the product, problem and actions to be taken. The customers were instructed to immediately stop using the product; to discard any remaining inventory and complete and return the Customer Acknowledgement Form by September 4, 2012 documenting the # of kits destroyed via FAX to Quality Assurance at 203-602-5553. The customers were also instructed to return the form even if they do not have the affected product currently in inventory. Sekisui will replace kits. If you have any questions contact, Customer Service Department at 800-637-3375, ext 10, 12, or 31, or email to recall coordinator at MKHAN@AMDIAG.COM.

Device

Device Recall Spectrolyse PAI1
  • Model / Serial
    Lot Numbers: 120425 and 120601
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: USA including states of: FL, IN, IL, and WA.
  • Product Description
    Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasminogen Activator Inhibitor Type- 1 (PAI-1) activity in human plasma. || Catalog Number: 101201 || For the determination of Plasminogen Activator Inhibitor Type 1 (PAI-1) activity in human plasma. The test is for in Citro diagnostic use.
  • Manufacturer
    Sekisui Diagnostics Llc

Manufacturer

Sekisui Diagnostics Llc
  • Manufacturer Address
    Sekisui Diagnostics Llc, 500 West Avenue, Stamford CT 06902
  • Manufacturer Parent Company (2017)
    Sekisui Chemical Co. Ltd.
  • Source
    USFDA