Date Initiated by Firm |
August 10, 2006 |
Date Posted |
November 14, 2006 |
Recall Status1 |
Terminated 3 on February 22, 2016 |
Recall Number |
Z-0167-2007 |
Recall Event ID |
36508 |
Product Classification |
Instrument Manager - Product Code JQP
|
Product |
Data 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 |
Recalling Firm/ Manufacturer |
Data Innovations, Inc. 120 Kimball Ave Ste 100 South Burlington VT 05403-6837
|
For Additional Information Contact |
Dave Potter 802-858-3424
|
Manufacturer Reason for Recall |
Patient results may be associated with an incorrect specimen
|
FDA Determined Cause 2 |
Other |
Action |
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. |
Quantity in Commerce |
187 |
Distribution |
Worldwide distribution (USA and Canada) |
Total Product Life Cycle |
TPLC 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.
|