Z-2305-2012Class II

syngo(R) Lab Data Manager and syngo(R) Lab Process Manager, all versions. This device is classified as a data...

Name: Z-2305-2012 syngo(R) Lab Data Manager and syngo(R) Lab Process Manager, all versions. This device is classified as a data...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2012-05-29
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2012-05-29 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of syngo(R) Lab Data Manager and syngo(R) Lab Process Manager, all versions. This device is classified as a data calculator and processing module for use with... on 2012-05-29. FDA classified it as Class II and gives the reason as "When using the syngo Quality Control package the system may not perform as intended for Multi-Rule QC violation [e.g., 2(2S), 4(1s) and 10x], unless configured using the instructions on page 2 of the recall...". 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-2305-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-29
Posted: 2012-08-31
Terminated: 2014-04-10
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: syngo(R) Lab Data Manager and syngo(R) Lab Process Manager, all versions. This device 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: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: When using the syngo Quality Control package the system may not perform as intended for Multi-Rule QC violation [e.g., 2(2S), 4(1s) and 10x], unless configured using the instructions on page 2 of the recall notification. QC status may not be flagged appropriately. If auto-verification rules are defined to hold patient results when QC status is out, the patient results will not be held as expecte
Root cause tag: software
FDA root cause: Software design
Action: Siemens sent a Urgent Field Safety Notice letter dated May, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter instructed the customers to re-set the Multi-Rule option and instructions are provided on how to do so. This recall notification also included a Field Safety Effectiveness check form to please fax to the Siemens Technical Solutions Center at 302-631-8467 BY June 15th.
Quantity in commerce: 44
Distribution: USA ( nationwide ) including the states of AZ, CA, FL, IL, KY, MD, MA, MN, MS, MO, NE, NH, NJ, NY, NC, OH, PA, TX, VA and WV.
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-2305-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2305-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-12	2012-08-31

Product code JQP

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)