Recall Z-0810-2007 ยท CEW Radioimmunoassay, Parathyroid Hormone
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.
| Date | May 16, 2007 (initiated Apr 19, 2007) |
| Status | Terminated |
| Reason | Negative bias caused by hemolysis interference at the low end of the reference range could cause erroneous diagnosis of hypoparathyroidism. |
| Root cause | 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 | 14,503 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992680 | ELECSYS PARATHYROID HORMONE TEST SYSTEM Roche Diagnostics Corp., Sep 28, 1999 |