Events

Recall of Device Recall Pacific Hemostasis Fibrinogen Degradation Products

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

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
    77340
  • Event Risk Class
    Class 2
  • Event Number
    Z-2762-2017
  • Event Initiated Date
    2017-05-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155789
  • 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
    System, fibrinogen determination - Product Code KQJ
  • Reason
    An issue was discovered with the pacific hemostasis fibrinogen degradation products (fdp) kit, list number 100650, lot 948546 and fdp latex reagent, list 100651, lot 890199. while the kit performs accurately at fdp concentrations greater than 20 ¿g/ml, there is an observed reduction in sensitivity when fdp levels are less than 20 ¿g/ml. this reduction in sensitivity has been tied to fdp latex reagent lot 890199 and may result in false negatives.
  • Action
    ThermoFisher Scientific sent an MEDICAL DEVICE RECALL Letter dated May 16, 2017, to all affected customers and response forms were sent to customers on May 19, 2017. Customers are informed of the recall and potential health risks and instructed to review their test results. Review your inventory and any product on hand is to be discarded. --- The firm ceased distribution of the lots and began its investigation. The held product will ultimately be destroyed. Level A effectiveness checks will be conducted to the consignees and repeated attempts will be made to non-responding customers. The firm will track all mailed, emailed and faxed return forms for the duration of the recall. For further questions, please call (540) 869-8188.

Device

Device Recall Pacific Hemostasis Fibrinogen Degradation Products
  • Model / Serial
    Lot Number 948546, Exp. 9/30/2017
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA (nationwide) including Puerto Rico, and Internationally to Colombia
  • Product Description
    Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI 00845275000863, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company LLC ,a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA --- For determination of Fibrinogen Degradation products in serum and urine.
  • Manufacturer
    Fisher Diagnostics

Manufacturer

Fisher Diagnostics
  • Manufacturer Address
    Fisher Diagnostics, 8365 Valley Pike, Middletown VA 22645-1905
  • Source
    USFDA