—#158433

Product

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

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K110413
Affected lot / code info: Software version PLC V26R10

Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

BEC will initiate a SW update- to fix the SW defect. This will be executed via MOD (field modification) performed by Field Service.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: China France Italy Kuwait Spain Turkey United States

Timeline

Recall initiated: 2017-08-03
Terminated: 2023-09-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #158433. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.