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U.S. Department of Health and Human Services

Class 2 Device Recall Roche PTH

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  Class 2 Device Recall Roche PTH see related information
Date Initiated by Firm April 19, 2007
Date Posted May 16, 2007
Recall Status1 Terminated 3 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/
Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46250-0416
For Additional Information Contact
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 2
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 and Original Applicant = ROCHE DIAGNOSTICS CORP.