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U.S. Department of Health and Human Services

Class 2 Device Recall Roche Cobas driver

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  Class 2 Device Recall Roche Cobas driver see related information
Date Initiated by Firm November 03, 2006
Date Posted November 29, 2006
Recall Status1 Terminated 3 on June 11, 2015
Recall Number Z-0224-2007
Recall Event ID 36752
Product Classification analytical laboratory data interface. - Product Code JQP
Product Roche Cobas driver (rchcob6i), analytical laboratory data interface.
Code Information Software version: v8.00.0001 and v7.00.0001
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
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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