Recall Z-2212-2011 ยท LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Beckman Coulter Inc.
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.
| Date | May 19, 2011 (initiated May 7, 2009) |
| Status | Terminated |
| 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. |
| Root cause | Other |
| 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 recov |
| Quantity | 5 units total |
| Distribution | Nationwide Distribution including VA KY and CA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.