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Z-1234-2014 Class II Terminated

Recalled by Medical Information Technology, Inc. — Canton, MA

FDA device recall Z-1234-2014 was initiated by Medical Information Technology, Inc. on Feb 21, 2014 and is designated Class II. Reason for recall: Potential for erroneous result reporting. The recall status is terminated (terminated Nov 12, 2015). Affected quantity: 438.

Recall Details

Product Type: Devices
Report Date: Mar 26, 2014
Initiation Date: Feb 21, 2014
Termination Date: Nov 12, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 438

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.

Distribution Pattern

Distributed USA (nationwide) and Canada.

Code Information

Client Server Releases 5.6, 5.65, 5.66, 5.67, 6.0, 6.05, 6.07, 6.1, 6.13 and 6.14.