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Recall Observatory FDA recall evidence

Device product

Power Processor 1K Stockyard. The Power Processor performs all pre-analytical sample tube preparation.

Z-0046-2018

August 03, 2017

Class II

Product summary

Firm
Beckman Coulter Inc.
Event
Event 77982
Status
Terminated
Classification
Class II
Quantity
27 units
Official record key
device-enforcement:Z-0046-2018

Official wording

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.

Code information: Software version PLC V26R10

Distribution pattern: China France Italy Kuwait Spain Turkey United States

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software nonconformity the 1K Stockyard can