Events

Rappel de Device Recall Bio Rad brand VARIANT II TURBO Hemoglobin Alc 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
    54483
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1932-2011
  • Date de mise en oeuvre de l'événement
    2009-12-01
  • Date de publication de l'événement
    2011-04-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-08-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88565
  • 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
    Some customers have reported the occurrence of some ramping baselines on the chromatograms. the ramping baseline can affect hemoglobin test results.
  • Action
    Bio Rad Laboratories, Inc. sent an Urgent Medical Device Correction letter dated December 1, 2009, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediatey examine their records to identify all customers who received one of the affected lots. Collect a Customer Medical Device Correction Response Form from every customer. Once forms were received from all applicable customers, complete the following Medical Device Correction Response Form and fax it to Bio-Rad CSD Regulatory Affairs at 510-741-3954 or pdf to CSD Recall Coordinator (excluding USSD). For questions regarding this recall call 510-724-7000.

Device

Device Recall Bio Rad brand VARIANT II TURBO Hemoglobin Alc Program
  • Modèle / numéro de série
    Catalog No. 270-2415: LOTS: Lot 70291500 Exp. June 30, 2010;  Lot 70292239 Exp. June 30, 2010; and Lot 70292240 Exp. June 30, 2010.  Catalog No. 270-2417: LOTS: Lot 70291520 Exp. Dec. 2, 2009; Lot 70292241 Exp.Dec.2, 2009; Lot 70291520R Exp. Jan. 31, 2010; Lot 70292242 Exp.Jan.31, 2010; and Lot 70292318 Exp. Jan. 31, 2010
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Australia, New Zealand, Taiwan, Singapore, India, China, S. Korea, Hong Kong, France, Sweden, United Kingdom, Italy, Hungary, Germany, Brazil, Mexico and Colombia.
  • Description du dispositif
    Bio Rad brand VARIANT II TURBO Hemoglobin Alc Program, 1600 and 2000 tests Cartridge Sets. Catalog Numbers: 270-2417 and 270-2415; Distributed and Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA || The Intended Use is as follows: The Bior-Rad II TURBO Hemoglobin A1c Program is intended for the percent determination of hemoglobin Alc in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). The Bio-Rad VARIANT II. TURBO Hemoglobin Alc Program is intended for Professional Use Only--For In Vitro Diagnostic Use. Reagent Kit Information: The VARIANT II TURBO Hemoglobin A1c program utilizes principles of ion¿exchange high performance liquid chromatography (HPLC). The VARIANT II Hemoglobin A1c Program is based on chromatographic separation of HbAlc on a cation exchange cartridge. System Overview: The VARIANT II TURBO Hemoglobin testing System provides an integrated method for sample preparation, separation and the percent determination of percent hemoglobin Alc in EDTA human whole blood. Technology Overview: The V ARIANT II TURBO Hemoglobin Testing is a fully automated, high-¿throughput hemoglobin analyzer. It consists of two modules- the VARIANT II Chromatographic Station (VCS) and the VARIANT II Sampling Station (VSS). In addition, a personal computer is used to control the VARIANT II TURBO System using Clinical Data Management (CDM) software. CDM is a dedicated software package of instrument control, data control, results analysis, calibration, quality control and service software.
  • Manufacturer
    Bio-Rad Laboratories Inc

Manufacturer

Bio-Rad Laboratories Inc
  • Adresse du fabricant
    Bio-Rad Laboratories Inc, 4000 Alfred Nobel Dr, Hercules CA 94547-1803
  • Source
    USFDA