Recall Z-1234-2014 ยท JQP Calculator/Data Processing Module, For Clinical Use
Medical Information Technology, Inc.
MEDITECH Microbiology; Client Server Releases 5.6, 5.65, 5.66, 5.67, 6.0, 6.05, 6.07, 6.1, 6.13 and 6.14. Integrates requisition, specimen processing, and patient information with data in the healthcare information system (HCIS).
| Date | Mar 19, 2014 (initiated Feb 21, 2014) |
| Status | Terminated |
| Reason | Potential for erroneous result reporting. |
| Root cause | Device Design |
| Action | Beginning on February 3, 2014 MEDITECH distributed a notification to Client Server customers who have the Microbiology product in TEST and/or LIVE only for the releases noted in this correction report. This notification was made via e-mailed task updates that can be printed by the customer. Task updates sent via e-mail are immediately transmitted to the customer. The issue will be corrected by CS LAB DTS 12279. |
| Quantity | 438 |
| Distribution | Distributed USA (nationwide) and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.