| 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. |
| FEI Number |
1823260
|
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 |
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| Action | A recall letter dated 7/14/06 instructs users to discontinue use of the product and to discard it. |
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| Quantity in Commerce | 1970 |
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| Distribution | Nationwide. |
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| 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
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