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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm August 06, 2004
Date Posted September 02, 2004
Recall Status1 Terminated 3 on June 26, 2006
Recall Number Z-1431-04
Recall Event ID 29648
510(K)Number K953239  
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product Roche/Hitachi Modular Additional D Module DAT clinical chemistry analyzer; catalog number 04429389160.
Code Information All units.
Recalling Firm/
Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact Technical Support
Manufacturer Reason
for Recall
A software defect will allow the reporting out of believable, but clinically significant, erroneous results under certain conditions.
FDA Determined
Cause 2
Action Recall letters dated 8/6/04 were sent to each customer advising them of the problem and giving instructions on how to avoid it.
Distribution United States.
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.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = BOEHRINGER MANNHEIM CORP.