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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 Managersee related information
Date Initiated by FirmMay 20, 2014
Date PostedJune 30, 2014
Recall Status1 Terminated 3 on August 10, 2015
Recall NumberZ-1944-2014
Recall Event ID 68394
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Productsyngo Lab Data Manager, SMN 10800057, 10803189, and 10804573.
Code Information syngo Lab Data Manager Application Software versions VA11B, VA12A, and VA12B
Recalling Firm/
Manufacturer
Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
PO BOX 6101
Newark DE 19702-2466
For Additional Information ContactCustomer Support
800-441-9250
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
ActionAn 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 Commerce336
DistributionWorldwide 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 CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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