Atlas FDA

Instrument Manager -Software Versions 8.05, 8.06, 8.07, 8.08, and 8.09. It is a stand-alone software package that provid

FDA device recall Z-0083-2012 · posted 2011-10-21 · Terminated

Recall details

Recalling firm
Data Innovations, Inc.
Reason for recall
The "previous result" retrieved from the Specimen Management Database may not be the most recent "previous result".
Action taken
Data Innovations sent an "IMPORTANT PRODUCT NOTICE" dated May 11, 2009 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter offers temporary workarounds for customers to use until corrected versions of the software is complete. Versions of the corrections will be provided on a staggered schedule. Customers will be notified by e-mail. Questions regarding this notice are directed to Support at 802-658-1955.
Root cause
Software design
Status
Terminated
Product code
JQP
Quantity affected
188
Distribution
USA (nationwide) and the country of Canada.
Date initiated
2009-05-11
Date posted
2011-10-21
Date terminated
2011-10-25
Location
South Burlington, VT

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