Z-0046-2018 Class II Terminated
FDA device recall Z-0046-2018 was initiated by Beckman Coulter Inc. on August 3, 2017 and is designated Class II. 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… The recall status is terminated (terminated September 27, 2023). Affected quantity: 27 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 1, 2017
- Initiation Date
- August 3, 2017
- Termination Date
- September 27, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27 units
Product Description
Power Processor 1K Stockyard. The Power Processor performs all pre-analytical sample tube preparation.
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.
Distribution Pattern
China France Italy Kuwait Spain Turkey United States
Code Information
Software version PLC V26R10