Z-0046-2018Class II

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

Name: Z-0046-2018 Power Processor 1K Stockyard. The Power Processor performs all pre-analytical sample tube preparation
Creator: Beckman Coulter Inc.
Published: 2017-08-03
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2017-08-03 / Terminated / root cause: software

FDA source

Beckman Coulter Inc. began a recall of Power Processor 1K Stockyard. The Power Processor performs all pre-analytical sample tube preparation on 2017-08-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0046-2018
Classification: Class II
Status: Terminated
Initiated: 2017-08-03
Posted: 2017-10-24
Terminated: 2023-09-27
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Power Processor 1K Stockyard. The Power Processor performs all pre-analytical sample tube preparation.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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.
Root cause tag: software
FDA root 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
Product codes and lots: Software version PLC V26R10

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0046-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0046-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-01	2017-10-24

Product code JJE

K110413Class IIPower Processor Sample Processing System with Generic ConnectionsBeckman Coulter, Inc. / cleared 2011-05-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)