Device Recall AutoMate TM Sample Processing System 의 리콜

Recall

55207

Class 2

Z-2212-2011

2009-05-07

2011-05-19

Terminated

United States

2012-06-28

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90304

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.

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