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.
Hazard
Negative bias caused by hemolysis interference at the low end of the reference range could cause erroneous diagnosis of hypoparathyroidism.
What You Should Do
Remedy
The firm issued a letter dated 04/19/07 to all users informing them of the change in the hemoglobin interference claim.
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Products
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.
- Brand
- Roche Diagnostics Corp.
- UPC
- 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.
Units Affected
14,503