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U.S. Department of Health and Human Services

Enforcement Report - Week of May 29, 2013

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Product Detail

Product Description TD-Synergy. Laboratory Information System.
Recall Number Z-1345-2013
Classification Class II
Code Info 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
Product Distributed Qty 10
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.

Event Detail

Event Id 56447
Product Type Devices
Status Ongoing
Recalling Firm Technidata S.A.
City Montbonnot St Martin
Country FR
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2010-07-29
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution-USA (nationwide) including Washington DC and the states of California, Nevada, Kentucky, Alabama, Rhode Island, Pennsylvania, and Louisiana and the country of Italy.