Z-0561-2014Class II

Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052

Name: Z-0561-2014 Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2013-05-06
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2013-05-06 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product Usage: Used in the Dimension(R) system with the heterogeneous module on 2013-05-06. FDA classified it as Class II and gives the reason as "Siemens Healthcare Diagnostics received complaints of Chemistry Wash causing QC and patient sample result shifts on CTN1, LTN1, FT4, TSH, PBNP and LPBN when using Chemistry Wash lots RD23031, RD23111, RD23241, RD23311...". 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-0561-2014
Classification: Class II
Status: Terminated
Initiated: 2013-05-06
Posted: 2013-12-24
Terminated: 2014-08-27
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product Usage: Used in the Dimension(R) system with the heterogeneous module
Product code: JMG Radioimmunoassay (Two-Site Solid Phase), Ferritin
Reason for recall: Siemens Healthcare Diagnostics received complaints of Chemistry Wash causing QC and patient sample result shifts on CTN1, LTN1, FT4, TSH, PBNP and LPBN when using Chemistry Wash lots RD23031, RD23111, RD23241, RD23311, RD23391, and RD23461. These lots shipped between 12/12/2012 and 3/22/2013. Internal investigation has confirmed shifts can be encountered in two scenarios: 1 - When an affected l
Root cause tag: software
FDA root cause: Software design
Action: Siemens sent an Urgent Medical Device Recall letter dated May 2013 to all affected customers. The letter identified the product and lots, the reason for the field action, the risk to health and the action(s) to be taken. Customers were instructed to discontinue use and discard inventory of the affected product. Siemens will replace any unused inventory of the affected lots at no charge. For questions contact your Siemens Technical Center or your local Siemens technical support representative.
Quantity in commerce: 17,719
Distribution: US Nationwide and OUS.
Product codes and lots: Lot numbers RD23031, exp 2013-04-29; RD23111, exp 2013-05-07; RD23241, exp 2013-05-19; RD23311, exp 2013-06-04; and RD23461, exp 2013-06-11

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0561-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0561-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-01	2013-12-23

Product code JMG

K963498Class IIFerr Flex Reagent CartridgeDade Chemistry Systems, Inc. / cleared 1997-01-24

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)