Events

Rappel de IsSyphilis TREPCHEK Test Kit.

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 Diamedix Corporation.

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
    30165
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0325-05
  • Date de mise en oeuvre de l'événement
    2003-09-11
  • Date de publication de l'événement
    2004-12-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2009-10-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35294
  • 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
    Enzyme Linked Immunoabsorption Assay, Treponema Pallidum - Product Code LIP
  • Cause
    Several customers complained that either the negative control index value exceeded the upper control limit or there was very low activity of the cut off calibrator causing patient sample test runs to be called invalid.
  • Action
    Recall letter dated 10/8/03 was sent, via FEDEX, with replacement conjugate bottles to those accounts reporting remaining stock.The letter requested that the original conjugate bottle, lot number 42023 be discarded and replaced with new conjugate lot #71323z. The letter also included a new inner box label that had the lot number information for the new conjugate bottle.

Device

IsSyphilis TREPCHEK Test Kit.
  • Modèle / numéro de série
    The kit lot number is 42003. The conjugate lot number is 42023.
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed to 54 laboratory accounts throughout the US.
  • Description du dispositif
    The Is-Syphilis TREP-CHEK (TM) Test Kit is a confirmatory in vitro enzyme immunoassay for the qualitative detection of Treponema pallidum IgG antibodies in human serum or plasma. The reagents can be used either manually or in conjunction with the MAGO Plus or APTUS Automated EIA Processors. The FDA has not cleared this product for use in screening blood or plasma donors. || The kit is labeled with an expiration date of Mar 04 and requires storage at 2-8 degree Centigrade.The non conforming kit component is the Conjugate that consists of a glass bottle with red cap containing 30 ml goat anti-human IgG labeled with horseradish peroxidase.
  • Manufacturer
    Diamedix Corporation

Manufacturer

Diamedix Corporation
  • Adresse du fabricant
    Diamedix Corporation, 2140 N Miami Ave, Miami FL 33127-4916
  • Source
    USFDA