Class 2 Device Recall Roche PTH

• Date Initiated by Firm: April 19, 2007
• Date Posted: May 16, 2007
• Recall Status: Terminated on June 11, 2008
• Recall Number: Z-0810-2007
• Recall Event ID: 37761
• 510(K)Number: K992680
• Product Classification: in vitro diagnostic - Product Code CEW
• Product: Roche PTH (parathyroid hormone test system) for use in conjunction with Roche cobas e 411, cobas e 601, Elecsys 1010, Elecsys 2010 and Modular E 170 analyzers; catalog no. 11972103122.
• Code Information: Lots 17723501, exp. 1/31/08; 17723502, exp. 1/31/08; 17642601, exp. 11/30/07; 17642602, exp. 11/30/07; 17450901, exp. 5/31/07; 17450902, exp. 5/31/07 and 17450903, exp. 5/31/07.
• Recalling Firm/ Manufacturer: Roche Diagnostics Corp.; 9115 Hague Rd; Indianapolis IN 46250-0416
• For Additional Information Contact: 800-428-2336
• Manufacturer Reason for Recall: Negative bias caused by hemolysis interference at the low end of the reference range could cause erroneous diagnosis of hypoparathyroidism.
• FDA Determined Cause: Other
• Action: The firm issued a letter dated 04/19/07 to all users informing them of the change in the hemoglobin interference claim.
• Quantity in Commerce: 14,503
• 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 = CEW