Date Initiated by Firm | April 25, 2003 |
Date Posted | May 29, 2003 |
Recall Status1 |
Terminated 3 on June 19, 2003 |
Recall Number | Z-0871-03 |
Recall Event ID |
26091 |
510(K)Number | K984104 |
Product Classification |
Immunoassay Method, Troponin Subunit - Product Code MMI
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Product | Elecsys Troponin T STAT; catalog number 2017423 |
Code Information |
All lots |
Recalling Firm/ Manufacturer |
Roche Diagnostics Corp. 9115 Hague Road Indianapolis IN 46250-0457
|
For Additional Information Contact | 800-428-2336 |
Manufacturer Reason for Recall | Hemoglobin interference limitation revised downward; hemolyzed samples may result in false negative results. |
FDA Determined Cause 2 | Other |
Action | An Urgent Product Correction letter was mailed to each account, during the week of 4/21/03, advising them not to use hemolyzed specimens with a hemoglobin level equal to, or greater than, 0.1 g/dL. |
Distribution | United States |
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.
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510(K) Database | 510(K)s with Product Code = MMI
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