Atlas FDA

Data Innovations Instrument Manager Version 8:00, 8.01, 8.02, 8.03 or 8.04 with Specimen Management and using Results/Ed

FDA device recall Z-0167-2007 · posted 2006-11-14 · Terminated

Recall details

Recalling firm
Data Innovations, Inc.
Reason for recall
Patient results may be associated with an incorrect specimen
Action taken
Data Innovations notified customers by an email listserv notification and by letter dated 8/17/06. A patch would be available on the website to be downloaded.
Root cause
Other
Status
Terminated
Product code
JQP
Quantity affected
187
Distribution
Worldwide distribution (USA and Canada)
Date initiated
2006-08-10
Date posted
2006-11-14
Date terminated
2016-02-22
Location
South Burlington, VT

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