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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 FirmJuly 14, 2004
Date PostedJuly 31, 2004
Recall Status1 Terminated 3 on October 14, 2004
Recall NumberZ-1303-04
Recall Event ID 29550
510(K)NumberK864082 
Product Classification Nadh Oxidation/Nad Reduction, Ast/Sgot - Product Code CIT
ProductRoche brand Reflotron GPT (ALT) 30 test strips; catalog # 745138.
Code Information Lot 23717132; exp 5/31/2005.
Recalling Firm/
Manufacturer
Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information ContactTechnical Service
800-428-4674
Manufacturer Reason
for Recall
Coating defect may result is falsely decreased patient and/or control results.
FDA Determined
Cause 2
Other
ActionRecall letters dated 7/14/04 were sent to each customer asking that use of these lots be stopped immediately. Testing labs were asked to notify the attending physician for any patients tested with these test strips.
Quantity in Commerce197 boxes
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 = CIT
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