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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmAugust 06, 2004
Date PostedSeptember 02, 2004
Recall Status1 Terminated 3 on June 26, 2006
Recall NumberZ-1432-04
Recall Event ID 29648
510(K)NumberK901003 
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
ProductRoche/Hitachi 747 - 200 clinical chemistry analyzer; catalog number 04009223680.
Code Information All units.
Recalling Firm/
Manufacturer		 Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information ContactTechnical Support
800-428-2336
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		Other
ActionRecall letters dated 8/6/04 were sent to each customer advising them of the problem and giving instructions on how to avoid it.
DistributionUnited States.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JJE
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