Events

Recall of Device Recall AutoMate TM Sample Processing System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Beckman Coulter Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    55207
  • Event Risk Class
    Class 2
  • Event Number
    Z-2212-2011
  • Event Initiated Date
    2009-05-07
  • Event Date Posted
    2011-05-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90304
  • Notes / Alerts
    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.
  • Extra notes in the data
    Equipment laboratory, general purpose, labeled or promoted for a specific medical use - Product Code LXG
  • Reason
    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
  • Model / Serial
    Lot number - N/A. P/N - A20745.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including VA KY and CA
  • Product Description
    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.
  • Manufacturer Address
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA