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U.S. Department of Health and Human Services

Class 2 Device Recall Data Innovations

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 Class 2 Device Recall Data Innovationssee related information
Date Initiated by FirmAugust 10, 2006
Date PostedNovember 14, 2006
Recall Status1 Terminated 3 on February 22, 2016
Recall NumberZ-0167-2007
Recall Event ID 36508
Product Classification Instrument Manager - Product Code JQP
ProductData Innovations Instrument Manager Version 8:00, 8.01, 8.02, 8.03 or 8.04 with Specimen Management and using Results/Edit/ReleaseScreen (R/E/R)
Code Information Software Versions:  8:00, 8.01, 8.02, 8.03 or 8.04
FEI Number 3001451449
Recalling Firm/
Manufacturer		 Data Innovations, Inc.
120 Kimball Ave Ste 100
South Burlington VT 05403-6837
For Additional Information ContactDave Potter
802-858-3424
Manufacturer Reason
for Recall		Patient results may be associated with an incorrect specimen
FDA Determined
Cause 2		Other
ActionData 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.
Quantity in Commerce187
DistributionWorldwide distribution (USA and Canada)
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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