—#110419

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

FDA product code: NSX
Affected lot / code info: Version VA11B and all previously released versions.

Why it was recalled

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 (FDA determination)

Software design (manufacturing process)

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 GBC Drive PO BOX 6101, Mailstop 514, Newark, Delaware 19714-6101

Distribution

Distribution pattern: USA (nationwide) including the states of AZ, CA, MS, MO, NJ, NC, OH, OR, PA, and TX.

Timeline

Recall initiated: 2012-06-07
Posted by FDA: 2012-08-09
Terminated: 2014-04-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #110419. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.