Events

Rappel de Device Recall PF4 Concentrated Wash

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Genetic Testing Institute,inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    70012
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1001-2015
  • Date de mise en oeuvre de l'événement
    2014-12-15
  • Date de publication de l'événement
    2015-01-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-04-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132110
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Platelet factor 4 radioimmunoassay - Product Code LCO
  • Cause
    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
  • Modèle / numéro de série
    Reagent Lot Numbers: 3001620, 3001987, 3002083, 3002153
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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 )
  • Description du dispositif
    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
  • Adresse du fabricant
    Genetic Testing Institute,inc, 20925 Crossroads Cir Ste 200, Waukesha WI 53186-4054
  • Source
    USFDA