Recall Z-0977-2007 ยท NHG Enzyme Immunoassay, Cortisol, Salivary
Roche Diagnostics Corp.
Roche Cortisol reagent for use in conjunction with Roche cobas e 411, cobas e 601, Elecsys 1010, Elecsys 2010 and Modular E 170 analyzers; Catalog no. 11875116122. in vitro diagnostic.
| Date | Jun 28, 2007 (initiated May 15, 2007) |
| Status | Terminated |
| Reason | The test is not as sensitive, or as precise between runs, as claimed in the labeling. Low concentrations are observed only in saliva samples. |
| Root cause | Other |
| Action | The firm notified consignees via letter dated 5/15/07 and notifed them of the changes to functional sensitivity and between-run precision claims. |
| Quantity | 6051 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043175 | ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE Roche Diagnostics Corp., Nov 24, 2004 |