Recall Z-1365-2013 ยท OUG Medical Device Data System
Medical Information Technology, Inc.
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.
| Date | May 22, 2013 (initiated May 7, 2013) |
| Status | Terminated |
| Reason | Incorrect transmission of laboratory results. |
| Root cause | 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 |
| Quantity | 56 devices |
| Distribution | Worldwide Distribution - USA, including Puerto Rico and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.