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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/
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 2		 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 and Original Applicant = ROCHE DIAGNOSTICS CORP.
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