Power Processor 1K Stockyard. The Power Processor performs all pre-analytical sample tube preparation.
FDA Recall Z-0046-2018 · Posted None
Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeJJE
Date Initiated2017-08-03
Date Terminated2023-09-27
Product Quantity27 units
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.
Firm Action
BEC will initiate a SW update- to fix the SW defect. This will be
executed via MOD (field modification) performed by Field Service.
Root Cause
Software design
Distribution Pattern
China France Italy Kuwait Spain Turkey United States
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.