Z-2173-2012Class II

Siemens syngo(R) Lab Data Manager. The syngo(R) Lab Data Manager is classified as a data calculator and...

Name: Z-2173-2012 Siemens syngo(R) Lab Data Manager. The syngo(R) Lab Data Manager is classified as a data calculator and...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2012-06-07
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2012-06-07 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Siemens syngo(R) Lab Data Manager. The syngo(R) Lab Data Manager is classified as a data calculator and processing module for use with In-vitro diagnostic... on 2012-06-07. FDA classified it as Class II and gives the reason as "The recalling firm has discovered that when using a Sysmex(R) CA-7000 or CA-1500 coagulation analyzer with the syngo Lab Data Manager (LDM), there is a potential for the syngo LDM system, to display and transmit to the...". 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-2173-2012
Classification: Class II
Status: Terminated
Initiated: 2012-06-07
Posted: 2012-08-09
Terminated: 2014-04-01
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Siemens syngo(R) Lab Data Manager. The syngo(R) Lab Data Manager is classified as a data calculator and processing module for use with In-vitro diagnostic devices. It also provides work flow management as well as remote instrument control to multiple interfaced instruments
Product code: NSX
Reason for recall: The recalling firm has discovered that when using a Sysmex(R) CA-7000 or CA-1500 coagulation analyzer with the syngo Lab Data Manager (LDM), there is a potential for the syngo LDM system, to display and transmit to the LIS an incorrect result following the syngo LDM's application of the configured result number format. The problem is encountered when the result number format configured on the Sys
Root cause tag: software
FDA root cause: Software design (manufacturing process)
Action: Siemens Healtcare Diagnostics sent a Urgent Field Safety Notice dated June 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised to discuss the contents of this letter with your Laboratory Director regarding the need to review any previous test results. If you have any technical questions or concerns, please contact the Seimens Technical Solutions Center at 1-800-441-9250, for further assistance.
Quantity in commerce: 15
Distribution: USA (nationwide) including the states of AZ, CA, MS, MO, NJ, NC, OH, OR, PA, and TX.
Product codes and lots: Version VA11B and all previously released versions.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2173-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2173-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-15	2012-08-09

Product code NSX

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)