Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1124-2014Class II

MEDITECH Microbiology - Calculator/data processing module, for clinical use

Medical Information Technology, Inc. / initiated 2014-01-17 / Terminated / root cause: design

Medical Information Technology, Inc. began a recall of MEDITECH Microbiology - Calculator/data processing module, for clinical use on . FDA classified it as Class II and gives the reason as "Potential for patient results being removed from LAB/EMR". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1124-2014
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Medical Information Technology, Inc.
Product
MEDITECH Microbiology - Calculator/data processing module, for clinical use.
Product code
JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall
Potential for patient results being removed from LAB/EMR.
Root cause tag
design
FDA 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 in commerce
737
Distribution
Worldwide Distribution: US (nationwide) and to countries of: Canada, Ireland, and United Kingdom.
Product codes and lots
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.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1124-2014
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1124-2014Class IITerminatedVoluntary: Firm initiated