Events

Recall of Device Recall PF4 Concentrated Wash

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Genetic Testing Institute,inc.

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
    70012
  • Event Risk Class
    Class 2
  • Event Number
    Z-1001-2015
  • Event Initiated Date
    2014-12-15
  • Event Date Posted
    2015-01-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-04-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132110
  • 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
    Some lots of pf4 concentrated wash (10x) are a slightly more dilute concentration. this may lead to slightly increased optical density (od) values. samples with a higher background reactivity may demonstrate false positive result (borderline reactivity) at or near the cutoff for the assay.
  • Action
    Immucor sent an Urgent - Field Safety Notice letter dated December 15, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised to stop using the recalled product and to destroy it. Requested consignees to complete the Customer Response From and return to waukeshatechsupport@immucor.com. Please contact Technical Support should you need additional information at 262.754.1000 or waukeshatechsupport@immucor.com.

Device

Device Recall PF4 Concentrated Wash
  • Model / Serial
    Reagent Lot Numbers: 3001620, 3001987, 3002083, 3002153
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - Nationwide Distribution to the states of : AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN,TX, UT, VA, WA, WV and WI., and the countries of : Canada, Japan, Belgium, European Union , Australia, Taiwan, Thailand and Scotland. ( some countries not yet identified )
  • Product Description
    PF4 Concentrated Wash (10x), REF 403624, packaged in the following assay kits: 1. ImmucorGamma LIFECODES PF4 IgG (catalog numbers HAT13G, HAT45G) and || 2. ImmucorGamma LIFECODES PF4 Enhanced (catalog numbers X-HAT13, X-HAT45) || The PF4 IgG assay is an Enzyme Linked Immunosorbent Assay (ELISA). The || PF4 IgG ELISA is intended to detect IgG antibodies in human serum that react || with Platelet Factor 4 (PF4) when it is complexed to heparin or other polyanionic || compounds. The PF4 IgG kit contains all of the reagents necessary to perform || the assay.
  • Manufacturer
    Genetic Testing Institute,inc

Manufacturer

Genetic Testing Institute,inc
  • Manufacturer Address
    Genetic Testing Institute,inc, 20925 Crossroads Cir Ste 200, Waukesha WI 53186-4054
  • Source
    USFDA