Recall Z-0046-2018
Beckman Coulter Inc. · initiated August 3, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Power Processor 1K Stockyard. The Power Processor performs all pre-analytical sample tube preparation.
Codes / lots: Software version PLC V26R10
Reason for recall
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.
FDA-determined cause: Software design
Action taken
BEC will initiate a SW update- to fix the SW defect. This will be executed via MOD (field modification) performed by Field Service.
Details
- Recall number
- Z-0046-2018
- Initiated
- August 3, 2017
- Terminated
- September 27, 2023
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Quantity
- 27 units
- Distribution
- China France Italy Kuwait Spain Turkey United States
- Recalling firm
- Beckman Coulter Inc., Brea, CA