Roche Diagnostics Corp. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Roche Diagnostics Corp.
Lot Codes / Batch Numbers
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.
Products Sold
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.
Roche Diagnostics Corp. is recalling Roche PTH (parathyroid hormone test system) for use in conjunction with Roche cobas e 411, cobas e 6 due to Negative bias caused by hemolysis interference at the low end of the reference range could cause erroneous diagnosis of hypoparathyroidism.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Negative bias caused by hemolysis interference at the low end of the reference range could cause erroneous diagnosis of hypoparathyroidism.
Recommended Action
Per FDA guidance
The firm issued a letter dated 04/19/07 to all users informing them of the change in the hemoglobin interference claim.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026