Z-1365-2013 Class II Terminated
FDA device recall Z-1365-2013 was initiated by Medical Information Technology, Inc. on May 7, 2013 and is designated Class II. Reason for recall: Incorrect transmission of laboratory results. The recall status is terminated (terminated October 1, 2014). Affected quantity: 56 devices.
Recall Details
- Product Type
- Devices
- Report Date
- May 29, 2013
- Initiation Date
- May 7, 2013
- Termination Date
- October 1, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 56 devices
Product 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.
Reason for Recall
Incorrect transmission of laboratory results.
Distribution Pattern
Worldwide Distribution - USA, including Puerto Rico and the country of Canada.
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