Class 2 Device Recall MEDITECH Microbiology

• Date Initiated by Firm: February 21, 2014
• Date Posted: March 19, 2014
• Recall Status: Terminated 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: 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.