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U.S. Department of Health and Human Services

Class 2 Device Recall MEDITECH BiDirectional LAB Analyzer Interface

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 Class 2 Recall
MEDITECH BiDirectional LAB Analyzer Interface
see related information
Date Posted May 22, 2013
Recall Status1 Open
Recall Number Z-1365-2013
Recall Event ID 65158
Product Classification Medical Device Data System - Product Code OUG
Product MEDITECH Bi-Directional interactive Communication Analyzer Interface; Integrates with MEDITECH's Laboratory Information System (LIS) with Other Vendor systems to manage the transfer of patient results and demographic information.
Code Information Magic Releases 5.41, 5.52. 5.53, 5.62, 5.63, 5.64 and Client Server Releases 5.64, 5.65, 6.05, 6.06, 6.07
Recalling Firm/
Manufacturer
Medical Information Technology, Inc.
Meditech Circle
Westwood, Massachusetts 02090
For Additional Information Contact Paul Berthiaume
781-821-3000 Ext. 5742
Manufacturer Reason
for Recall
Incorrect transmission of laboratory results.
FDA Determined
Cause 2
DESIGN: Device Design
Action Beginning on May 7, 2013, MEDITECH distributed a notification to MAGIC and Client Server customers who have the MEDITECH Bi-Directional Interactive Communication Analyzer Interface in use with Vitros 3600, 4600, or 5600 Analyzer in TEST and/or LIVE. This notification was made via remailed task updates that can be printed by the customer. Task updates sent via e-mail are immediately transmitted to the customer. This notification informs customers of the potential patient safety issue that could result in reporting inaccurate qualitative results. Customers will receive a corrective change, in which the previous test's results will no longer be associated with the test not performed. Until customers receive the corrective change, they are instructed to monitor all No Result values from their analyzer and confirm that the result in MEDITECH matches. For further questions please call 781-821-3000, ext. 5742.
Quantity in Commerce 56 devices
Distribution Worldwide Distribution - USA, including Puerto Rico and the country of Canada.
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.
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