Date Initiated by Firm |
November 03, 2006 |
Date Posted |
November 29, 2006 |
Recall Status1 |
Terminated 3 on June 11, 2015 |
Recall Number |
Z-0223-2007 |
Recall Event ID |
36752 |
Product Classification |
analytical laboratory data interface. - Product Code JQP
|
Product |
Roche Modular Drive (rchmdlri), analytical laboratory data interface. |
Code Information |
Software Version: v8.00.0016, v8.00.0017, v7.00.0023 and v7.00.0024 |
Recalling Firm/ Manufacturer |
Data Innovations, Inc. 120 Kimball Ave Ste 100 South Burlington VT 05403-6837
|
For Additional Information Contact |
Katharine Laddison 802-264-3420
|
Manufacturer Reason for Recall |
Software of modular driver may incorrectly report patient results as Quality Control Results
|
FDA Determined Cause 2 |
Software change control |
Action |
Data Innovations notified users by email listserv and by letter dated 10/25/06. |
Quantity in Commerce |
56 |
Distribution |
Nationwide and Canada. |
Total Product Life Cycle |
TPLC Device Report
|
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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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