Recall Z-0810-2007

Roche Diagnostics Corp. · initiated April 19, 2007

Terminated

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.

Codes / lots: 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.

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 taken

The firm issued a letter dated 04/19/07 to all users informing them of the change in the hemoglobin interference claim.

Details

Recall number
Z-0810-2007
Initiated
April 19, 2007
Posted by FDA
May 16, 2007
Terminated
June 11, 2008
Product code
CEW – Radioimmunoassay, Parathyroid Hormone
Quantity
14,503
Distribution
Nationwide.
Recalling firm
Roche Diagnostics Corp., Indianapolis, IN

Official FDA recall record