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U.S. Department of Health and Human Services

Class 2 Device Recall Elecsys

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  Class 2 Device Recall Elecsys see related information
Date Initiated by Firm January 31, 2006
Date Posted February 09, 2006
Recall Status1 Terminated 3 on April 10, 2006
Recall Number Z-0512-06
Recall Event ID 34491
510(K)Number K984105  K040733  K051752  
Product Classification Immunoassay Method, Troponin Subunit - Product Code MMI
Product Roche brand Elecsys Troponin T; catalog number 2017644.
Code Information Lot 171924-02.
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 false negative result may be reported.
FDA Determined
Cause 2
Other
Action Recall letter dated 1/31/06 was issued to each customer instructing them to stop using, and to discard, the product.
Quantity in Commerce 3116 kits
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 = MMI and Original Applicant = BOEHRINGER MANNHEIM CORP.
510(K)s with Product Code = MMI and Original Applicant = Roche Diagnostics
510(K)s with Product Code = MMI and Original Applicant = ROCHE DIAGNOSTICS CORP.
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