Events

Recall of Device Recall ZYMUTEST HIA MonoStrip IgGAM ELISA

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
    79797
  • Event Risk Class
    Class 2
  • Event Number
    Z-1743-2018
  • Event Initiated Date
    2018-02-05
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163463
  • 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
    Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. the kits should only be used with plasma.
  • Action
    On March 6, 3018 Aniara Diagnostica began emailing Urgent Medical Device Recall notifications to affected customers. Customers are instructed to: Use the US Instructions for Use and Return the completed Acknowledgement Awareness Form. Customers with questions may contact Aniara Diagnostica via e-mail at Sandra@aniara.com or by phone at (866)783-3797 ext. 110.

Device

Device Recall ZYMUTEST HIA MonoStrip IgGAM ELISA
  • Model / Serial
    Lot numbers: F1600568P1, F1701370P1, F1701370P2
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    OH, MD, NC, NY, NH, Canada, Sweden
  • Product Description
    ZYMUTEST HIA MonoStria qualitative screening assay intended for the global detection of heparin-dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma, by clinical laboratories. p IgGAM; REF Number: RK041D; UDI: 03663537046810
  • 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