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U.S. Department of Health and Human Services

Class 2 Device Recall syngo Lab Data Manager

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 Class 2 Device Recall syngo Lab Data Manager see related information
Date Posted June 30, 2014
Recall Status1 Terminated on August 10, 2015
Recall Number Z-1944-2014
Recall Event ID 68394
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573.
Code Information syngo Lab Data Manager Application Software versions VA11B, VA12A, and VA12B
Recalling Firm/
Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
PO BOX 6101
Newark DE 19702-2466
For Additional Information Contact Customer Support
Manufacturer Reason
for Recall
Certain configuration parameters may cause the reference ranges to not hold results as expected and release them to the Laboratory Information System (LIS) that should have been held for manual review.
FDA Determined
Cause 2
Device Design
Action An urgent medical device correction notice, dated May 20, 2014, was sent to end users to provide instructions to avoid potential risks associated with the software defect, until changes can be made by a Siemens technical representative.
Quantity in Commerce 336
Distribution Worldwide Distribution. US Nationwide, Canada, Australia, Belgium, Czech Republic, Germany, Denmark, Finland, France, United Kingdom, Italy, Netherlands, Portugal, Slovakia, Singapore, Japan, and Spain.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.