Events

Rappel de Liquichek ToRCH Plus IgM Control

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 Bio-rad Laboratories, 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
    64959
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1330-2013
  • Date de mise en oeuvre de l'événement
    2013-04-15
  • Date de publication de l'événement
    2013-05-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-08-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117531
  • 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
    Multi-analyte controls, all kinds (assayed) - Product Code JJY
  • Cause
    The liquichek" torch plus igm control - positive, contains detectable levels of hcv rna which originated from the non-specific human igm component used in the mouse monoclonal antibody conjugation process for this product.
  • Action
    Bio-rad Laboratories initiated this recall on April 18, 2013, via telephone call and certified mailing to customers. The notification letter titled "Important Product Information Notice of Correction" was accompanied by a "Field Correction Notification Acknowledgement" form that notified customers of the product for recall (description and codes), issue (This product contains detectable levels of HCV RNA which originated from the non-specific human IgM component used in the mouse monoclonal antibody conjugation process for this product), Customers were instructed to immediately discontinue use this lot of Liquichek ToRCH Plus IgM Control. Discard all remaining inventory of this lot of Liquichek ToRCH Plus IgM Control that you have at your location in accordance with the requirements of your local waste management authorities. Handle this product with the same precautions used with patient specimens. In accordance with good laboratory practice, all human source material should be considered potentially infectious. Have the appropriate laboratory personnel complete the acknowledgment form and email or fax it to us. It is very important to us to know that you have received the information provided in this Notice. Contact information (1-800-2-BIORAD)

Device

Liquichek ToRCH Plus IgM Control
  • Modèle / numéro de série
    Lot Number 18972, Catalog Number 229 and 229PX.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - Distributed in San Juan Puerto Rico and the states of NM, NY, MN, OR and WI., and the countries of Australia, Brazil, France, Italy, Korea, and New Zealand.
  • Description du dispositif
    Liquichek" ToRCH Plus IgM Control - Positive || Liquichek ToRCH Plus IgM Control is intended for use as an unassayed quality control serum to monitor precision of IgM laboratory testing procedures for the analytes listed in this package insert. This product is not intended for use in blood donor screening assays. Analytes claimed with this lot of Liquichek ToRCH Plus IgM Control: ¿ Cytomegalovirus (CMV) IgM ¿ Herpes Simplex Virus Type 1/2 (HSV-1/2) IgM ¿ Rubella Virus IgM ¿ Toxoplasma gondii IgM
  • Manufacturer
    Bio-rad Laboratories, Inc.

Manufacturer

Bio-rad Laboratories, Inc.
  • Adresse du fabricant
    Bio-rad Laboratories, Inc., 9500 Jeronimo Rd, Irvine CA 92618-2017
  • Société-mère du fabricant (2017)
    Bio-Rad Laboratories Inc
  • Source
    USFDA