Recall Z-0046-2018 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter Inc.
Power Processor 1K Stockyard. The Power Processor performs all pre-analytical sample tube preparation.
| Date | Aug 3, 2017 |
| Status | Terminated |
| Reason | Beckman Coulter has identified that due to a PLC software nonconformity the 1K Stockyard can initiate a retrieval of a sample tube during the rack loading process, which should not occur. This issue and associated complaint were discovered and filed internally. |
| Root cause | Software design |
| Action | BEC will initiate a SW update- to fix the SW defect. This will be executed via MOD (field modification) performed by Field Service. |
| Quantity | 27 units |
| Distribution | China France Italy Kuwait Spain Turkey United States |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110413 | POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS Beckman Coulter, Inc., May 11, 2011 |