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.
Recall
- Recall Number
- Z-1365-2013
- Event Number
- 65158
- Firm
- Medical Information Technology, Inc. Meditech Circle
- FEI Number
- 1000120736
- Product Code
- OUG
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- May 7, 2013
- Posted
- May 22, 2013
- Terminated
- October 1, 2014
- Address
- Westwood, MA, 02090
Description
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.
Incorrect transmission of laboratory results.
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.
Worldwide Distribution - USA, including Puerto Rico and the country of Canada.
56 devices