Events

Recall of Sekisui Diagnostics, Spectrolyse PAI1 catalog 101201

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
    63615
  • Event Risk Class
    Class 2
  • Event Number
    Z-0463-2013
  • Event Initiated Date
    2012-10-24
  • Event Date Posted
    2012-12-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-01-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114366
  • 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 0 iu/ml standard reducing the slope of the standard curve requiring more frequent sample dilutions.
  • Action
    Sekisui Diagnostics issued an "URGENT PRODUCT RECALL NOTICE" dated October 24, 2012 to all consignees. The letter instructed consignees to immediately stop using the specified lot of product, discard any remaining inventory and return the enclosed response form. Contact the Customer Service Department at 800-637-3375, ext. 10, 12, or 31 for assistance with this recall.

Device

Sekisui Diagnostics, Spectrolyse PAI1 catalog 101201
  • Model / Serial
    Lot # 120827, exp 11/27/2012
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution-including the states of FL, IN, NC, OH, UT, and WA.
  • Product Description
    Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative determination of Plasminogen Activator Inhibitor Type 1 in human plasma. || Catalog # 101201. || Spectrolyse PAI-1 is intended for the quantitative determination of Plasminogen Activator Inhibitor Type-1 (PAI-1) activity in human plasma. The test is for in vitro 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