Events

Recall of Device Recall Hemoliance 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
    Recall
  • Event ID
    35632
  • Event Risk Class
    Class 2
  • Event Number
    Z-1247-06
  • Event Initiated Date
    2006-03-07
  • Event Date Posted
    2006-07-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-08-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46522
  • 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.

Device

Device Recall Hemoliance RecombiPlasTin
  • Model / Serial
    Product No.49732750 (5 mL): Lots N0448239, N0549190, N0940581, N0353406, N0857200, N1050152; Product No. 49732720 (20 mL): Lots N0347895, N0548959, N0749495, N0940543, N0940586, N1242409, N0353410, N0454257, N0857199, N1050143.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Hemoliance RecombiPlasTin. Prothrombin Time Test. The product is available as a kit of 25 vials of Hemoliance¿ RecombiPlasTin matched with 25 vials of Hemoliance¿ RecombiPlasTin Diluent. Hemoliance¿ RecombiPlasTin after reconstitution with Hemoliance¿ RecombiPlasTin Diluent is a liposomal preparation of recombinant human tissue factor and purified phospholipids, calcium chloride, buffer and a preservative. The use of recombinant human tissue factor and purified phospholipids assures uniformity in reagent purity, ISI values and performance from lot to lot. Once reconstituted, it is ready for use in the one-stage PT test. Hemoliance¿ RecombiPlasTin Diluent is an aqueous solution of calcium chloride and a preservative. --- FOR IN VITRO DIAGNOSTIC USE.
  • Manufacturer
    Instrumentation Laboratory Co.

Manufacturer

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