Events

Rappel de Amplicor [3] AV-HRP. (Avidin-HRP (Horseradish Peroxidase) BGG Conjugate.) || Kit: Amplicor CT/NG CT Detection 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 Roche Molecular Systems 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
    29566
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1360-04
  • Date de mise en oeuvre de l'événement
    2004-07-07
  • Date de publication de l'événement
    2004-08-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2005-01-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34122
  • 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
    Dna Probe, Nucleic Acid Amplification, Chlamydia - Product Code MKZ
  • Cause
    An increased frequency of 'blue foci' that potentially can cause elevated a450 background in microwell plate wells after the addition of conjugate reagent during pcr detection.
  • Action
    With respect to U.S distribution, email/letter on 6/24/04 to the local safety officers and general managers stationed at the affiliated distribution center, Roche Diagnostics Corporation of Indianapolis, IN. With respect to overseas distributors, email/letter on 6/24/04 to the local safety officers and general managers stationed at the affiliated distribution centers. Roche stated that the local safety officer is responsible to communicate the advisory both to the customers/end-users and the regulatory authority of the country. On July 6, 2004, a Revised Important Product Advice Notice was sent out to affiliates requiring the immediate discontinuation of the use of the affected kits, and destruction of any kits remaining in customers hands.

Device

Amplicor [3] AV-HRP. (Avidin-HRP (Horseradish Peroxidase) BGG Conjugate.) || Kit: Amplicor CT/N...
  • Modèle / numéro de série
    Amplicor [3] AV-HRP, Lot No. E09569 found in kit lot:  Lot No. E12231, Material No. 2075932018, Exp. 2/2005
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    ♦ Amplicor CT/NG CT Detection Kit, Lot No.E12231, Material No.20759392018, Expiration 2/2005 , Shipped To: Roche Diagnostics Corporation, 9115 Hague Road, P.O. Box 50457 Indianapolis, IN 46250-0457. ♦ Amplicor CT/NG NG Detection Kit, Lot No.E12647, Material No.20759406018, Expiration 2/2005, Shipped To: Roche Diagnostics Corporation, 9115 Hague Road, P.O. Box 50457 Indianapolis, IN 46250-0457. ♦ Amplicor HCV Detection Kit, v2.0, Lot No.F01023, Material No.21118439018, Expiration 5/2005, Shipped To: Roche Diagnostics Corporation, 9115 Hague Road, P.O. Box 50457 Indianapolis, IN 46250-0457. ♦ Amplicor IC Detection Kit, 96 tests, Lot No.E09554, Material No.20751952018, Expiration 5/2005, Shipped To: Roche Diagnostics Corporation, 9115 Hague Road, P.O. Box 50457 Indianapolis, IN 46250-0457. Export-U.S Distributed Products: AmpliCap HCV Monitor Test, Lot No.E09193, Material No.21111337018, Expiration 8/2004 , Shipped To: Roche Diagnostics KK, Nippon Roche KK, Kamakura Factory 200, Aza Sotokochi, Kajiwara, Kamakura City, Kanagawa Pref, Japan. Amplicor IC Detection Kit, Lot No.E13115, Material No.20763306122, Expiration 7/2005, Shipped To: Roche Diagnostics KK, Nippon Roche KK, Kamakura Factory 200, Aza Sotokochi, Kajiwara, Kamakura City, Kanagawa Pref, Japan; Shipped To: Roche Diagnostics Canada, 201 Boulevard Armand-Frappier, Laval QC H7V 4A2, Canada; Shipped To: Roche Diagnostics GmbH, GX-OSW, Sandhoferstr. 116, D-68305 Mannheim. Amplicor M. avium Detection Kit, Lot No.E12990, Material No.20759880018, Expiration 11/2004, Shipped To: Roche Diagnostics KK, Nippon Roche KK, Kamakura Factory 200, Aza Sotokochi, Kajiwara, Kamakura City, Kanagawa Pref, Japan. Amplicor MTB Detection Kit, Lot No.E13307, Material No.20757462122, Expiration 9/2004, Shipped To: Roche Diagnostics KK, Nippon Roche KK, Kamakura Factory 200, Aza Sotokochi, Kajiwara, Kamakura City, Kanagawa Pref, Japan; Shipped To: Roche Diagnostics Canada, 201 Boulevard Armand-Frappier, Laval QC H7V 4A2, Canada Shipped To: Roche Diagnostics GmbH, GX-OSW, Sandhoferstr. 116, D-68305 Mannheim. Amplicor NG Detection Kit, Lot No.E10894, Material No.20744026122, Expiration 2/2005, Shipped To: Roche Diagnostics KK, Nippon Roche KK, Kamakura Factory 200, Aza Sotokochi, Kajiwara, Kamakura City, Kanagawa Pref, Japan ; Shipped To: Roche Diagnostics Canada, 201 Boulevard Armand-Frappier, Laval QC H7V 4A2, Canada; Shipped To: Roche Diagnostics GmbH, GX-OSW, Sandhoferstr. 116, D-68305 Mannheim. There are no Govt. accounts.
  • Description du dispositif
    Amplicor [3] AV-HRP. (Avidin-HRP (Horseradish Peroxidase) BGG Conjugate.) || Kit: Amplicor CT/NG CT Detection Kit
  • Manufacturer
    Roche Molecular Systems Inc

Manufacturer

Roche Molecular Systems Inc
  • Adresse du fabricant
    Roche Molecular Systems Inc, 11 Franklin Ave, Belleville NJ 07109-3501
  • Source
    USFDA