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/ Manufacturer |
Roche Diagnostics Corp. 9115 Hague Rd Indianapolis IN 46256-1025
|
For Additional Information Contact |
800-428-2336
|
Manufacturer Reason for Recall |
A design change in the electrodes will result in incorrect potassium level results.
|
FDA Determined Cause 2 |
Other |
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
|
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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.
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