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U.S. Department of Health and Human Services

Class 2 Device Recall Roche Cortisol reagent

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  Class 2 Device Recall Roche Cortisol reagent see related information
Date Initiated by Firm May 15, 2007
Date Posted June 28, 2007
Recall Status1 Terminated 3 on June 11, 2008
Recall Number Z-0977-2007
Recall Event ID 37764
510(K)Number K043175  
Product Classification in vitro diagnostic - Product Code NHG
Product Roche Cortisol reagent for use in conjunction with Roche cobas e 411, cobas e 601, Elecsys 1010, Elecsys 2010 and Modular E 170 analyzers; Catalog no. 11875116122. in vitro diagnostic.
Code Information Lots 17592001, exp. 10/31/07; 17502002, exp. 10/31/07; 17733201, exp. 2/29/08; and 17733202, exp. 2/29/08.
Recalling Firm/
Manufacturer		 Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46250-0416
For Additional Information Contact
800-428-2336
Manufacturer Reason
for Recall		 The test is not as sensitive, or as precise between runs, as claimed in the labeling. Low concentrations are observed only in saliva samples.
FDA Determined
Cause 2		 Other
Action The firm notified consignees via letter dated 5/15/07 and notifed them of the changes to functional sensitivity and between-run precision claims.
Quantity in Commerce 6051
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 = NHG and Original Applicant = ROCHE DIAGNOSTICS CORP.
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