Recall of Device Recall HemosIL RecombiPlasTin

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Firm received 2 complaints concerning incorrect prothrombin time (pt) results while using the reagents on samples of patients taking the antibiotic cubicin (daptomycin for injection).
  • Action
    "Urgent Product Notifications" were sent to IL customers on 3/07/06 through its distributor, Beckman Coulter.


  • Model / Serial
    Product No.0020002900 (8mL): Lots N0649021, N0253072, N0253739, N1150411; Part No. 0020003000 (20 mL): Lots N0347531, N0447950, N0740293, N1040969, N1141498, N0152736, N0453415, N0454252, N0756711, N0958473, N1150445, N1250485, N1250619, N0160792.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
  • Product Description
    HemosIL RecombiPlasTin. Prothrombin Time Test. Each RecombiPlasTin kit consists of: RecombiPlasTin (RTF): 5 x 8 mL or 20 mL vials of lyophilized recombinant human tissue factor, synthetic phospholipids with stabilizers, preservative and buffer; and RecombiPlasTin Diluent (RTF Diluent): 5 x 8 or 20 mL vials of an aqueous solution of calcium chloride, polybrene and a preservative. --- || FOR IN VITRO DIAGNOSTIC USE.
  • Manufacturer


  • Manufacturer Address
    Instrumentation Laboratory Co., 113 Hartwell Ave, Lexington MA 02421-3125
  • Source