Events

Rappel de VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 1600 tests,

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
    59868
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0020-2012
  • Date de mise en oeuvre de l'événement
    2011-09-12
  • Date de publication de l'événement
    2011-10-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-05-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103898
  • 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, glycoslylated hemoglobin - Product Code LCP
  • Cause
    A previous recall related to reports of calibration failure and late retention times using elution buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these products until a definitive root cause and corrective action have been found and implemented.
  • Action
    Bio-Rad sent an Urgent Medical Device Correction letter on September 12, 2011, to all affected subsidiaries and customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discard all affected product in accordance with all local, state and federal disposal procedures. If customers distributed the product further they should direct their customers to discard all unused product. Customers were asked to please translate (if necessary) the attached "Customer Medical Device Correction Response Form," customers should add their local contact information and distribute to all affected customers in their region by mail or fax. Compile tracking documentation (e.g. Excel spreadsheet) for all customers who received the Medical Device Correction Letter. Complete the "SUBSIDIARY MEDICAL DEVICE CORRECTION RESPONSE FORM" and fax to Bio-Rad Regulatory Affairs at (510) 741-3954, or e-mail PDF to CSD_RA/Hercules/US/BIO-RAD. Customers would be issued credits for the affected products based on their request. For questions call (510) 741-3954.

Device

VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 1600 tests,
  • Modèle / numéro de série
    Model number: 270-2417; Lot number 70211073, expiry 12/31/2011. Contains Buffer lot: AA10758/AA10759, expiry 12/31/11.
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and to New Zealand, Canada, France, England, China, India, Mexico, Italy, Brazil, Australia, Singapore, Thailand, SriLanka, hong Kong, Sweden, Germany, Peru, Jamaica, Uruguay, Columbia, Argentina, Chile, Paraguay and Korea.
  • Description du dispositif
    VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 1600 tests, || IVD, Made in United States. || Kit contains: || 1. Elution Buffer A 3 x 2500 mL, Bis-Tris Phosphate Buffer || 2. Elution Buffer B 1 x 1500 mL Bis-Tris Phosphate Buffer || 3. Cartridge Set, 2 cation exchange analytical cartridges, 4 cation exchange Guard cartridges. || 4. CD-ROM 1 - CD Rom with program parameters || 5. Calibration/Diluent set - 2 levels, 2 vial each of lyophilized human red blood cell hemolysate with preservative, 1 bottle diluent, 100 mL deionized water. || 6. Whole Blood Primer, 6 x 1 mL, lyophilized human red blood cell hemolysate with preservative, || 7. Sample vials - 2 x 100, 1.5 mL polypropylene vials with pierceable caps. || 8. Instruction Manual. || Bio-Rad Laboratories, Hercules, CA 94547. || Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
  • 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