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.
FDA Recall Z-1365-2013 · Posted 2013-05-22
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Recalling FirmMedical Information Technology, Inc.
Recall StatusTerminated
Product CodeOUG
Date Initiated2013-05-07
Date Terminated2014-10-01
Product Quantity56 devices
Reason for Recall
Incorrect transmission of laboratory results.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution - USA, including Puerto Rico and the country of Canada.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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