Class 2 Device Recall Power Processor 1K Stockyard

• Date Initiated by Firm: August 03, 2017
• Create Date: October 24, 2017
• Recall Status: Terminated on September 27, 2023
• Recall Number: Z-0046-2018
• Recall Event ID: 77982
• 510(K)Number: K110413
• Product Classification: Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
• Product: Power Processor 1K Stockyard. The Power Processor performs all pre-analytical sample tube preparation.
• Code Information: Software version PLC V26R10
• FEI Number: 2050012
• Recalling Firm/ Manufacturer: Beckman Coulter Inc.; 250 S Kraemer Blvd; Brea CA 92821-6232
• Manufacturer 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: BEC will initiate a SW update- to fix the SW defect. This will be executed via MOD (field modification) performed by Field Service.
• Quantity in Commerce: 27 units
• Distribution: China France Italy Kuwait Spain Turkey United States
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JJE