Class 2 Device Recall MEDITECH Microbiology

• Date Initiated by Firm: January 17, 2014
• Date Posted: March 03, 2014
• Recall Status: Terminated on June 06, 2016
• Recall Number: Z-1124-2014
• Recall Event ID: 67458
• Product Classification: Calculator/data processing module, for clinical use - Product Code JQP
• Product: MEDITECH Microbiology - Calculator/data processing module, for clinical use.
• Code Information: Model, catalogue, or product order number(s): MAGIC Releases 5.6, 5. 5.66 and Server Releases 5.6, 5.65. 6.0, 6.05, 6.06, 6.07, 6.1 and 6.13.
• 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 patient results being removed from LAB/EMR.
• FDA Determined Cause: Device Design
• Action: Beginning on January 17, 2014 MEDITECH distributed a notification to MAGIC and 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. Instructions provided to customers: Task Description: CS LAB DTS 11696/MG LAB DTS 16703 - MIC: Inactive procedure prompt not displaying previous results. We are setting up this task to inform you of a potential patient safety issue that may result in patient results being removed from LAB/EMR. This task will continue to be updated to provide you with the status on this issue and details on the deployment of changes to address. This issue has been determined to impact both Client Server and MAGIC 5.6 and higher. Until the changes to address above are delivered, please refrain from inactivating procedure prompts in the MIC Procedure Dictionary. Although patient results are not permanently deleted from the record, because of the potential impact on a patient should this issue occur and go undetected, we felt it necessary to inform you of the issue. We strongly recommend delivery of the changes to address the issue. ¿ We have engaged all necessary resources within MEDITECH to identify and resolve this issue as expediently as possible. ¿ CS LAB DTS 11696 - MIC: Inactive procedure prompt not displaying previous results ¿ MG LAB DTS 16703 - MIC: Inactive procedure prompt not displaying previous results ¿ Inactivating Procedure Prompts in the MIC Procedure Dictionary causes data to be removed from existing specimens. These results are also removed from the EMR. However, once the prompts are re-activated, the results are again present on the specimens. ¿ We strongly recommend delivery of this change to your system to alleviate this potential patient safety concern. Please confirm via this task th
• Quantity in Commerce: 737
• Distribution: Worldwide Distribution: US (nationwide) and to countries of: Canada, Ireland, and United Kingdom.
• 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.