FDA Medical Device Recalls (openFDA)
Medical Information Technology, Inc.: MEDITECH Microbiology - Calculator/data processing module, for clinical use.
- Recall number
- Z-1124-2014
- Recalling firm
- Medical Information Technology, Inc.
- Product
- MEDITECH Microbiology - Calculator/data processing module, for clinical use.
- Status
- Terminated
- Initiated
- 2014-01-17
- Posted
- 2014-03-03
- Terminated
- 2016-06-06
- Reason
- Potential for patient results being removed from LAB/EMR.
- Root 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
- 737
- Distribution
- Worldwide Distribution: US (nationwide) and to countries of: Canada, Ireland, and United Kingdom.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JQP
- Firm FEI
- 3009404844
- Firm city
- Canton
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28