Events

Recall of Device Recall ZYMUTEST HIA MonoStrip IgGAM

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

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
    79269
  • Event Risk Class
    Class 2
  • Event Number
    Z-1063-2018
  • Event Initiated Date
    2011-11-09
  • Event Date Posted
    2018-03-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161801
  • 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
    Platelet factor 4 radioimmunoassay - Product Code LCO
  • Reason
    A voluntary recall is initiated for zymutest hia lggam - ref rk040d - lot f1700415 and zymutest hia monostrip lggam - ref rk041d - lot f1700416 because they may produce false positive results.
  • Action
    The manufacturer, HYPHEN BioMed, initiated a voluntary recall of the two lots via email. Distributors and end users are being notified and instructed to: 1) acknowledge receipt and understanding of notification, and 2) destroy affected products remaining in stock. For further questions, please call (513) 770-1993.

Device

Device Recall ZYMUTEST HIA MonoStrip IgGAM
  • Model / Serial
    UDI: 03663537046810. Lot Number: F1700416.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution and to the countries of : Austria and France.
  • Product Description
    ZYMUTEST HIA MonoStrip IgGAM. || Model Number: RK041D. || Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 32 Tests.
  • Manufacturer
    Hyphen BioMed

Manufacturer

Hyphen BioMed
  • Manufacturer Address
    Hyphen BioMed, 155 rue d Eragny, Neuville Sur Oise France
  • Manufacturer Parent Company (2017)
    Hyphen Biomed
  • Source
    USFDA