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U.S. Department of Health and Human Services

Class 2 Device Recall MagNA Pure LC

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  Class 2 Device Recall MagNA Pure LC see related information
Date Initiated by Firm May 27, 2003
Date Posted July 15, 2003
Recall Status1 Terminated 3 on November 18, 2003
Recall Number Z-1001-03
Recall Event ID 26366
Product MagNA Pure LC Instrument; Catalog number 2236931.
Code Information All units with software version 3.0.
Recalling Firm/
Manufacturer		 Roche Diagnostics Corp.
9115 Hague Road
Indianapolis IN 46250-0457
For Additional Information Contact
800-428-5074
Manufacturer Reason
for Recall		 Potential for false negative patient results with software version 3.0
FDA Determined
Cause 2		 Other
Action An Urgent Product Correction letter dated 5/27/03 was sent to each customer.
Quantity in Commerce 17
Distribution California, Georgia, Illinois, Maine, Michigan, Mississippi, New York Ohio, Oregon, Pennsylvania, Texas, Utah, Wisconsin and Canada.
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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