MEDITECH Bi-Directional interactive Communication Analyzer Interface; Integrates with MEDITECH's Laboratory Information

FDA device recall Z-1365-2013 · posted 2013-05-22 · Terminated

Recall details

Recalling firm

Medical Information Technology, Inc.

Reason for recall

Incorrect transmission of laboratory results.

Action taken

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

Status

Terminated

Product code

OUG

Quantity affected

56 devices

Distribution

Worldwide Distribution - USA, including Puerto Rico and the country of Canada.

Date initiated

2013-05-07

Date posted

2013-05-22

Date terminated

2014-10-01

Location

Westwood, MA