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U.S. Department of Health and Human Services

Class 2 Device Recall MEDITECH Microbiology

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  Class 2 Device Recall MEDITECH Microbiology see related information
Date Initiated by Firm February 21, 2014
Date Posted March 19, 2014
Recall Status1 Terminated 3 on November 12, 2015
Recall Number Z-1234-2014
Recall Event ID 67584
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
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).
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.
Recalling Firm/
Manufacturer		 Medical Information Technology, Inc.
7 Blue Hill River Rd
Canton MA 02021-1001
For Additional Information Contact Paul Berthiaume
781-821-3000 Ext. 5742
Manufacturer Reason
for Recall		 Potential for erroneous result reporting.
FDA Determined
Cause 2		 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 in Commerce 438
Distribution Distributed USA (nationwide) and Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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