Events

Recall of Device Recall SimpliRED Ddimer Assay

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by BBI SOLUTIONS OEM LTD.

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
    74786
  • Event Risk Class
    Class 2
  • Event Number
    Z-0314-2017
  • Event Initiated Date
    2016-06-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148459
  • 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
    A component of the kit is showing a sensitivity performance detected in stability testing at 15 months of an 18-month shelf life. qualitative results may be affected. false negative results are possible which may incorrectly influence the clinical diagnostic decision.
  • Action
    BBI Solutions sent an Urgent Medical Device Recall letter dated June 30, 2016, to all affected customers. Customers were advised to immediately discontinue use of the product, consider the requirement for review of reported test results, complete and return the customer acknowledgement form to BBI Solutions and to complete and return the customer reconciliation form to the distributor. Customers who have forwarded product to other sites, should inform those customers of the product recall and provide them with a copy of the notice. Customers with questions were instructed to call Tel: +44(0)1382 564093.

Device

Device Recall SimpliRED Ddimer Assay
  • Model / Serial
    Lot Numbers containing test reagent lot # 1012-34437): BU183A, BU183B, BU184A, BU185A, BU185B Expiration Date: 31 JUL 2016
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US distribution to CT and IN
  • Product Description
    SimpliRED D-Dimer, Product Code DSRK4 || The SimpliRED D-dimer assay is a rapid, qualitative test for the detection of cross-linked fibrin degradation products containing the cross-linked D-diner site in human whole blood
  • Manufacturer
    BBI SOLUTIONS OEM LTD

Manufacturer

BBI SOLUTIONS OEM LTD
  • Manufacturer Address
    BBI SOLUTIONS OEM LTD, 8 Tom McDonald Avenue, Dundee United Kingdom
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA