—#90304

Product

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.

FDA product code: LXG — Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: Lot number - N/A. P/N - A20745.

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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

Recalling firm

Firm: Beckman Coulter Inc.
Address: 200 S Kraemer Blvd, Brea, California 92821-6208

Distribution

Distribution pattern: Nationwide Distribution including VA KY and CA

Timeline

Recall initiated: 2009-05-07
Posted by FDA: 2011-05-19
Terminated: 2012-06-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #90304. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.