Events

Rappel de Device Recall AutoMate TM Sample Processing System

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
    55207
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2212-2011
  • Date de mise en oeuvre de l'événement
    2009-05-07
  • Date de publication de l'événement
    2011-05-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-06-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90304
  • 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
    Equipment laboratory, general purpose, labeled or promoted for a specific medical use - Product Code LXG
  • Cause
    The recall was initiated because beckman coulter has confirmed an issue with the automate sample processing systems. if during the recovery from error 81201001, a stuck sample carrier with a tube is moved backwards to the loading position, sample tube/input tray information will become mismatched for samples being loaded onto the automate.
  • Action
    Beckman Coulter sent an Urgent Product Corrective Action letter dated May 7, 2009, with a Fax Back Response Form (sent by US mail) to all customers who received the AutoMate Sample Processing System. The letter identified the product, the problem and a workaround to correct the problem. Customers were instructed to take the following steps: If the stuck sample carrier is moved backwards during recovery from this error, the sample tube/input tray information will become mismatched. Figure 2 in the PCA letter shows the AutoMate viewed from the rear. Sequence 1 to 3 depicts the error recovery issue. The sample is loaded, but cannot move along the track. As the sample attempts to move along the track, it is captured by the track stopper (not seen) below the track. Error 81201001 will be displayed at the console with the following description: The stopper (SL01) did not stop the sample tube carrier.If the stopper or an operator forces the sample backward along the line, it will cause the information mismatch. If you encounter this scenario, do not move the carrier backward to the loading position. See Figure 3 in the PCA letter. Recovery from Error 81201001: 1. The normal recovery for error 81201001 is to move the sample carrier forward. If there is no room to do so in the Input module, extra steps must be taken for the carrier to move forward. a. Resume the module by performing error recovery on the Hardware Error Recovery screen at the console. b. Continue the console error recovery process until a carrier is released from BR01, thereby creating space for the stuck carrier to be pushed forward. c. Move the stuck sample carrier forward d. Once again, resume the module by performing error recovery on the Hardware Error Recovery screen. (The error should not return again) Recovery if Symptoms are Observed: 1. If the incorrect processing described above is observed, the system must be stopped immediately and shut down. All samples m

Device

Device Recall AutoMate TM Sample Processing System
  • Modèle / numéro de série
    Lot number - N/A. P/N - A20745.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including VA KY and CA
  • Description du dispositif
    AutoMate TM Sample Processing System, P/N A20745 Basic Assembly - Automate || The AutoMate system prepares sample tubes for diagnostic testing and for storage. The AutoMate system contains an automated track that connects to Input/Output, Centrifuge, Serum Level Detection, Decapper, and Output modules. The AutoMate TM 800 model also contains and Aliquot module.
  • 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