Recall Z-1345-2013— Technidata S.A.

Name: FDA recall Z-1345-2013
Creator: U.S. Food and Drug Administration
Published: 2010-07-29

Class II · Terminated

Class II FDA medical device recall by Technidata S.A., initiated 2010-07-29, terminated 2013-12-05. FDA's recall record names no specific 510(k) clearance for this event. Product: TD-Synergy. Laboratory Information System.. Reason: 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..

Recalling firm: Technidata S.A.
Classification: Class II
Status: Terminated
Initiated: 2010-07-29
Terminated: 2013-12-05
Firm location: Montbonnot St Martin, N/A, France

Product description

TD-Synergy. Laboratory Information System.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.