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U.S. Department of Health and Human Services

Class 2 Device Recall TDSynergy

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 Class 2 Device Recall TDSynergysee related information
Date Initiated by FirmJuly 29, 2010
Date PostedMay 21, 2013
Recall Status1 Terminated 3 on December 05, 2013
Recall NumberZ-1345-2013
Recall Event ID 56447
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
ProductTD-Synergy. Laboratory Information System.
Code Information TD Lims product versions: LIS (ALLX)-21.041-_ML-5370, LIS (ALLX)-22.021-_ML-5374, TD-Synergy product versions: SYN (ALLX)- 03.13B-_ML-5368, SYN (ALLX)- 03.141-_ML-5369, SYN(LINUX)-06.011-_ML-5381, SYN (ALLX)-11.11B-_ML-5345, SYN (ALLX)-11.21B-_ML-5346 SYN (ALL)- 11.31C-_ML-5372, SYN (LINUX)-11.321-_FR-5382, SYN (ALL)-11.321-_ML-5373 
FEI Number 3003995437
Recalling Firm/
Manufacturer		 Technidata S.A.
387, Avenue Jean Kuntzmannn
Montbonnot St Martin France
Manufacturer Reason
for Recall		Technidata has discovered that using the F8 key in the ERM session to add a combined test can result in the modification of the value of a result that has already been entered for a test of the request.
FDA Determined
Cause 2		Software design
ActionThe firm, Technidata, sent an "P1 DEFECT INFORMATION" notice dated July 2, 2010 to their consignee/customers. The notice describes the product, problem and actions to be taken. The notice directs them to find the correction to the software issue on the Technidata website where they are able to install the correction kit depending on the version and operating system used. Note "You must back up the database and the installation directory before installing this correction". Should you need any further information, do not hesitate to contact the Support team at +33 (0) 4 76 04 13 00.
Quantity in Commerce10
DistributionWorldwide Distribution-USA (nationwide) including Washington DC and the states of California, Nevada, Kentucky, Alabama, Rhode Island, Pennsylvania, and Louisiana and the country of Italy.
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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