Events

Rappel de Device Recall IMMAGE CReactive Protein (CRP) Reagent

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 Beckman Coulter 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
    48648
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0921-2010
  • Date de mise en oeuvre de l'événement
    2008-01-10
  • Date de publication de l'événement
    2010-03-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-07-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71801
  • 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
    C-Reactive Protein Antigen, Antiserum, and Control - Product Code DCK
  • Cause
    Immage crp reagent lots m705441, m709279, & m709319, may demonstrate a prozone or hook effect on samples with extremely high crp analyte concentration.
  • Action
    Customers were sent Urgent: Product Corrective Action letters dates, 1/22/2008. The letter identified the issue, discussed the impact, and listed the following actions/resolution. * To eliminate the hook effect when using these lots, run CRP samples beginning with the 1:216 dilution. ~ A limited correlation of patient samples run in the 1:36 dilution compared to the same samples run in the 1:216 dilution verifies acceptable performance (there may be a shift of up to 0.8 mg/dL for samples between 1.0 and 8.0 mg/dL). * Controls run in the 1:216 dilution may recover differently than those run in the default 1:36 dilution. A limited number of control samples were also run in the 1:216 dilution. * The IMMAGE 800 system can be set to default to a non-standard dilution for each chemistry. Change CRP to a Non-Standard Dilution of 1:216 in the Setup section of the software. Detailed instructions for configuring a Non-Standard dilution as default are located in chapter 5 of the IMMAGE 800 Immunochemistry System Operations Manual. * The IMMAGE system does not allow resetting the default dilution of a chemistry. Instructions for running CRP samples beginning in a Non-Standard Dilution are enclosed. * Complete and return the enclosed response form within 10 days so we may maintain our records. Customers are to share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. If you have forwarded any of the affected product listed above to another laboratory, please provide a copy of this letter to them. Questions regarding this letter should be directed to 800-854-3633 or customers can contact their local Beckman Coulter Representative

Device

Device Recall IMMAGE CReactive Protein (CRP) Reagent
  • Modèle / numéro de série
    Lots M705441, M709279, M709319
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution -- Including states of AL, CA, CT, DC, FL, FL ,GA, HI, IA, IL ,IN, KY ,MA, MD, ME, MI, MO, NE, NJ, NY, OH, OR, PA, RI, TX, VA, WI, and WV.
  • Description du dispositif
    IMMAGE Immunochemistry Systems C-Reactive Protein (CRP) Reagent, Part Number 447280. || Intended for the quantitative determination of C-Reactive Protein (CRP) in human serum or plasma by rate nephelometry.
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc
  • Adresse du fabricant
    Beckman Coulter Inc, 200 S Kraemer Blvd, Brea CA 92822-6208
  • Source
    USFDA