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U.S. Department of Health and Human Services

Class 2 Device Recall Roche/Hitachi K Electrode

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  Class 2 Device Recall Roche/Hitachi K Electrode see related information
Date Initiated by Firm July 14, 2006
Date Posted August 03, 2006
Recall Status1 Terminated 3 on December 04, 2007
Recall Number Z-1352-06
Recall Event ID 35793
510(K)Number K953239  
Product Classification in vitro diagnostic - Product Code CEM
Product Roche/Hitachi K Electrode, a potassium electrode for use with the Roche/Hitachi models 717,747, 902, 911,912, 917, Modular and cobas c 501 clinical chemistry analyzers; Roche Catalog/Part Number 10825441001/ US # 722-4402.
Code Information Lots L33 through L50 through L99 and all M series lots.
Recalling Firm/
Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact
Manufacturer Reason
for Recall
A design change in the electrodes will result in incorrect potassium level results.
FDA Determined
Cause 2
Action A recall letter dated 7/14/06 instructs users to discontinue use of the product and to discard it.
Quantity in Commerce 1970
Distribution Nationwide.
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 = CEM and Original Applicant = BOEHRINGER MANNHEIM CORP.