Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1234-2014Class II

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...

Medical Information Technology, Inc. / initiated 2014-02-21 / Terminated / root cause: design

Medical Information Technology, Inc. began a recall of 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... on . FDA classified it as Class II and gives the reason as "Potential for erroneous result reporting". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1234-2014
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Medical Information Technology, Inc.
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).
Product code
JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall
Potential for erroneous result reporting.
Root cause tag
design
FDA root 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.
Product codes and lots
Client Server Releases 5.6, 5.65, 5.66, 5.67, 6.0, 6.05, 6.07, 6.1, 6.13 and 6.14.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1234-2014
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1234-2014Class IITerminatedVoluntary: Firm initiated