Events

Recall of Pacific Hemostasis brand SickleScreen Sickling Hemoglobin Screening Kit

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
    30004
  • Event Risk Class
    Class 3
  • Event Number
    Z-1496-04
  • Event Initiated Date
    2004-09-03
  • Event Date Posted
    2004-09-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-05-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34990
  • 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, Sickle Cell - Product Code GHM
  • Reason
    Defective reaction vials from an in vitro diagnostic test kit may cause positive patient samples to be interpreted as false negatives.
  • Action
    The firm ceased distribution on 8/24/04 and initiated recall by certified letter dated 9/3/04, which was flagged as 'customer recall notification'. The notice advised of the defective vials and requested users to return response form with the numbers of kits to be returned for replacement.

Device

Pacific Hemostasis brand SickleScreen Sickling Hemoglobin Screening Kit
  • Model / Serial
    Lot 250-403 and 250-404, EXP 4/30/2006
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed through the manufacturer''s affiliate distribution company to 228 end users nationwide.
  • Product Description
    Pacific Hemostasis brand SickleScreen Sickling Hemoglobin Screening Kit, Fisher Diagnostics catalog number 100250, containing reagents for 30 determinations.
  • 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