Recall Z-1234-2014— Medical Information Technology, Inc.
Class II · Terminated
Class II FDA medical device recall by Medical Information Technology, Inc., initiated 2014-02-21, terminated 2015-11-12. FDA's recall record names no specific 510(k) clearance for this event. Product: 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).. Reason: Potential for erroneous result reporting..
- Recalling firm
- Medical Information Technology, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-02-21
- Terminated
- 2015-11-12
- Firm location
- Canton, MA, United States
Product description
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).
Reason for recall
Potential for erroneous result reporting.
Data sourced from openFDA. This site is unofficial and independent of the FDA.