Events

Recall of HemosIL ReadiPlasTin

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

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
    79165
  • Event Risk Class
    Class 2
  • Event Number
    Z-0895-2018
  • Event Initiated Date
    2017-08-02
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161501
  • 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, time, prothrombin - Product Code GJS
  • Reason
    Instrumentation laboratory co. received customer reports of performance issues with some vials of lot nos. n1166235 and n0177760, including increased imprecision, out of range quality controls and prolonged sample results.
  • Action
    Instrumentation Laboratory sent an Urgent Medical Device Removal letter dated August 2, 2017 to their customers. The letter identified the affected product, problem and actions to be taken. . Customers were instructed to complete a Mandatory Tracking Response form. For questions contact your Customer Service Representative at 1-800-955-9525, option #1.

Device

HemosIL ReadiPlasTin
  • Model / Serial
    Lots: N1166235 and N0177760.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide
  • Product Description
    Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400 || Product Usage: || HemosIL¿ ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP¿ Family of analyzers. The product is intended to be used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Vitamin K Antagonist Therapy.
  • Manufacturer
    Instrumentation Laboratory Co.

Manufacturer

Instrumentation Laboratory Co.
  • Manufacturer Address
    Instrumentation Laboratory Co., 180 Hartwell Rd, Bedford MA 01730-2443
  • Manufacturer Parent Company (2017)
    Werfenlife Sa.
  • Source
    USFDA