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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 FirmDecember 29, 2003
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on February 20, 2004
Recall NumberZ-0335-04
Recall Event ID 27989
510(K)NumberK945915 K954018 K972733 K990092 
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
ProductRoche brand OMNI 7 Analyzer; catalog numbers GD0435 and GD0435R.
Code Information All units.
Recalling Firm/
Manufacturer		 Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact
800-526-2272
Manufacturer Reason
for Recall		The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.
FDA Determined
Cause 2		Other
ActionA recall letter dated 12/29/03 was issued to each customer instructing them not to use the listed sample types.
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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