Events

Rappel de Synchron Systems(s) Creatinine Reagent (CREm)

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
    56424
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2389-2010
  • Date de mise en oeuvre de l'événement
    2010-08-02
  • Date de publication de l'événement
    2010-09-09
  • 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=93640
  • 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
    Alkaline picrate, colorimetry, creatinine - Product Code CGX
  • Cause
    The recall was initiated after beckman coulter confirmed reports that black / brown particulates were observed in some bottles of the creatinine alkaline buffer (buffer lot m911427 and m911518) in modular creatinine (crem) reagent kit lots m911428 and m911519. beckman coulter have had reports of erroneous results when using the lots of creatinine alkaline buffer listed above. single creatinine d.
  • Action
    The firm, Beckman Coulter, sent a "URGENT: PRODUCT CORRECTIVE ACTION" letter dated August 3, 2010, to all customers. The letter describes the product, problem, and action to be taken by customer. The customers were instructed to: (1) Please discontinue use of Creatinine (CREm) reagent kit lots M911428 and M911519 and discard appropriately. (2) Please contact Beckman Coulter at (800) 526-3821 in the United States or (800) 463-7828 in Canada to discuss CREm kit M911428 and M911519 replacement options. Outside the United States and Canada, please contact your local Beckman Coulter Representative. (3) Please complete and return the enclosed response form within 10 days so that we may maintain our records. (4) Please share this information with their laboratory staff and retain this notification as part of their Quality System documentation. If you have forwarded the affected products listed above to another laboratory, please provide a copy of this letter to them. If customers have any questions regarding this Product Corrective Action letter, they were instructed to please contact Beckman Coulter's Customer Support Center (Call Center) on the Beckman Coulter website at www.BeckmanCoulter.com/Customer Support/Support Requests, or call (800) 854-3633 in the United States and Canada.

Device

Synchron Systems(s) Creatinine Reagent (CREm)
  • Modèle / numéro de série
    Lot Number(s): M911428 & M911519
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, KS, LA, MA, ME, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV, and WY and country of Canada
  • Description du dispositif
    SYNCHRON Systems Modular Creatinine (CREm) Reagent Kit, Part Number: 472525 || Systems AQUA CAL 1 and 2, is intended for the quantitative determination of creatinine concentration in human serum, plasma or urine. || CREm reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 800 System and SYNCHRON Systems AQUA CAL 1 and 2, is intended for the quantitative determination of creatinine concentration in human serum, plasma or urine.
  • 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