Class 2 Device Recall Roche Cortisol reagent

• Date Initiated by Firm: May 15, 2007
• Date Posted: June 28, 2007
• Recall Status: Terminated 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: 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