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U.S. Department of Health and Human Services

Class 3 Device Recall Roche Hitachi K electrode

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 Class 3 Device Recall Roche Hitachi K electrodesee related information
Date Initiated by FirmJuly 21, 2006
Date PostedAugust 29, 2006
Recall Status1 Terminated 3 on November 01, 2006
Recall NumberZ-1447-06
Recall Event ID 35873
510(K)NumberK953239 
Product Classification Potassium electrode - Product Code CEM
ProductRoche/Hitachi K Electrode, a potassium electrode for use with the Roche/Hitachi models 717,747, 902, 911,912, 917, Modular and Cobas c 501clinical chemistry analyzers; Roche Catalog/Part Number 10825441001/ US # 722-4402.
Code Information Lots I90, I93 and I95 (alpha I and two digits)
Recalling Firm/
Manufacturer		 Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact
800-428-2336
Manufacturer Reason
for Recall		Expired product (dated 2006.06) was shipped as replacement for recalled product.
FDA Determined
Cause 2		Other
ActionConsignees were notified by phone and sent a recall letter dated 7/21/06 via fax, which instructed them to discontinue use of these lots of product and to discard them.
Quantity in Commerce137 electrodes
DistributionNationwide.
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 = CEM
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