Events

Rappel de Device Recall VARIANT II TURBO Link Hemoglobin A1c Program

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
    59659
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-3159-2011
  • Date de mise en oeuvre de l'événement
    2011-07-28
  • Date de publication de l'événement
    2011-09-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-11-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103233
  • 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
    Assay, glycosylated hemoglobin - Product Code LCP
  • Cause
    The elution buffer b, lot no. ga 10430, was shipped in a 2.0 l bottle instead of the standard 2.5 l bottle.
  • Action
    The firm, BIO-RAD, sent a "Medical Device Correction" letter dated July 28, 2011 to all consignees/customers via Fed Ex on August 8, 2011. The letter described the product, problem and actions to be taken. The customers were informed that they could continue to use and report results with the affected buffer lot and the stability studies will continue until lot expiration date. The consignees were instructed to distribute this letter to all customers that have received the affected lot and to distribute the MEDICAL DEVICE CORRECTION RESPONSE FORM only to those customers that request replacement Elution Buffer B. In addition, the customers were to complete and return the MEDICAL DEVICE CORRECTION RESPONSE FORM via fax to (510) 741-3954, Attention: BIO-Rad CSD Regulatory Affairs Department. If you have any questions, please contact your regional Bio-Rad office or 510-724-7000.

Device

Device Recall VARIANT II TURBO Link Hemoglobin A1c Program
  • Modèle / numéro de série
    Catalog Number: 270-2716; Reorder Pack Lot No: 70210702; Expires September 30, 2011. Elution Buffer B: Lot number 270-2718, lot number: GA10430, Exp 2/29/2012.
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: MD, MI, MN, NY, OH, SC, VA and WI.
  • Description du dispositif
    VARIANT II TURBO Link Hemoglobin A1c Program Reorder Pack. || Calibrator/Diluent Set. || IVD. || Kit components: || Elution Buffer A, 2 x 2500 mL || Elution Buffer B, 1 x 2100 mL || Wash/Diluent Solution, 1 x 2500 mL || Cartridge Set, 2 Cation exchange Analytical Cartridges, 4 Cation Guard Cartridges; || CD-ROM - || Calibration/Diluent Set, 2 levels, 2 vials each of lyophilized human red blood cell hemolysate with preservative, 1 bottle of diluent, 100 mL, deionized water || Whole Blood Primer, 6 x 1 mL || Sample Vials, 2 x 100 || Instruction Manual. || Bio-Rad Laboratories Inc. Hercules, CA 94547 || Intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (H LPC).
  • Manufacturer
    Bio-Rad Laboratories, Inc.

Manufacturer

Bio-Rad Laboratories, Inc.
  • Adresse du fabricant
    Bio-Rad Laboratories, Inc., 4000 Alfred Nobel Drive, Hercules CA 94547-1803
  • Société-mère du fabricant (2017)
    Bio-Rad Laboratories Inc
  • Source
    USFDA