Events

Recall of Pacific Hemostasis D-Dimer Assay Kit, Fisher Diagnostics Catalog Number 100660, packaged in a cardboard box containing materials and reagents to perform 80 tests.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Fisher Diagnostic, A Company of Fisher Scientific 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
    29573
  • Event Risk Class
    Class 3
  • Event Number
    Z-1336-04
  • Event Initiated Date
    2004-07-01
  • Event Date Posted
    2004-08-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-12-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34141
  • 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
    Fibrin Split Products - Product Code GHH
  • Reason
    Defective reagent may cause in vitro diagnostic test kit to yield false positive test results in clinical samples.
  • Action
    The recalling firm notified consignees on 7/1/04 by letter flagged as a customer notification. The notice describes the potential for invalid control results using the speckled cards. The letter requests users to return the cards for replacement. Defective cards are described as isolated to those packaged in heat sealed cellophane type bags. The firm requests customers to return a response form with quantity needed for replacement.

Device

Pacific Hemostasis D-Dimer Assay Kit, Fisher Diagnostics Catalog Number 100660, packaged in a car...
  • Model / Serial
    Lot 660-926 exp 10/31/04 Lot 660-927 exp 09/30/04 Lot 660-928 exp 11/30/04 Lot 660-929 exp 06/30/05 Lot 660-930 exp 03/31/05
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was sold primarily to clinical laboratories nationwide and to international distributors
  • Product Description
    Pacific Hemostasis D-Dimer Assay Kit, Fisher Diagnostics Catalog Number 100660, packaged in a cardboard box containing materials and reagents to perform 80 tests.
  • Manufacturer
    Fisher Diagnostic, A Company of Fisher Scientific LLC

Manufacturer

Fisher Diagnostic, A Company of Fisher Scientific LLC
  • Manufacturer Address
    Fisher Diagnostic, A Company of Fisher Scientific LLC, 8365 Valley Pike, Middletown VA 22645-1905
  • Source
    USFDA