Atlas FDA

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 req

FDA device recall Z-1234-2014 · posted 2014-03-19 · Terminated

Recall details

Recalling firm
Medical Information Technology, Inc.
Reason for recall
Potential for erroneous result reporting.
Action taken
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.
Root cause
Device Design
Status
Terminated
Product code
JQP
Quantity affected
438
Distribution
Distributed USA (nationwide) and Canada.
Date initiated
2014-02-21
Date posted
2014-03-19
Date terminated
2015-11-12
Location
Canton, MA

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