Events

Rappel de Device Recall Unicel Synchron Clinical Systems

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
    55163
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2442-2010
  • Date de mise en oeuvre de l'événement
    2010-01-18
  • Date de publication de l'événement
    2010-09-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-08-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90199
  • 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
    analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Cause
    The recall was initiated due to " a loose aliquot probe tube fitting in the closed tube aliquotter (cta), may result in erroneous access immunoassay results or synchron chemistry results". this may result in dilution of the sample with wash buffer; patient results can potentially be affected for access immunoassays or synchron chemistries. access quality control may also be affected if run throug.
  • Action
    Beckman Coulter sent an "URGENT: PRODUCT CORRECTIVE ACTION" letter dated January 18, 2010, to all affected customers. The letter provided the customer with an explanation of the problem identified, the affected product, and instructions for the customer. The letter requested customers complete the following actions for : (1) CTA Aliquot Probe Inspection and Maintenance: a. Check daily for signs of leaks or damage to the tube fitting by looking and feeling for liquid at the fitting, the end of the probe and the surrounding areas; b. The CTA Aliquot Probe tube fitting should be checked to ensure that it is connected tightly to the Aliquot Probe. Without loosening the tube fitting, ensure it is securely tightened; c. When replacing the CTA Aliquot Probe, ensure that the Aliquot Probe tube fitting is securely tightened, prime the CTA, inspect for leaks, and run Access Quality Control through the CTA; d. If a leaking Aliquot Probe is suspected, review all sample results for both Access and Synchron in light of the total clinical presentation of the patient including: symptoms, clinical history, data from additional tests, and other appropriate information; e. As this issue may result in dilution of the sample with Wash Buffer; it may be appropriate to discard and redraw any affected sample tubes run on the CTA. The letter also informed customers that Beckman Coulter is currently evaluating potential solutions for this issue and requested they share this information with laboratory staff and retain this notification as part of their laboratory Quality System documentation. If they forwarded the affected products to another laboratory, they were asked to provide a copy of this letter to them. They were also instructed to complete and return the enclosed response form within 10 days. Customers were told to call Customer Technical Support Center (Hotline) at (800) 854-3633 in the United States and Canada with any questions.

Device

Device Recall Unicel Synchron Clinical Systems
  • Modèle / numéro de série
    All Serial Numbers
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA: including the states of AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, AND WV and the country of Canada.
  • Description du dispositif
    Closed Tube Aliquotter (CTA) for UniCel || DxC 600i, Part Number: A25637, Domestic; A25633, International || The UniCel Synchron Clinical Systems are fully automated, computer controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent).
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Adresse du fabricant
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    USFDA