Roche Cortisol reagent for use in conjunction with Roche cobas e 411, cobas e 601, Elecsys 1010, Elecsys 2010 and Modula
FDA device recall Z-0977-2007 · posted 2007-06-28 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- The test is not as sensitive, or as precise between runs, as claimed in the labeling. Low concentrations are observed only in saliva samples.
- Action taken
- The firm notified consignees via letter dated 5/15/07 and notifed them of the changes to functional sensitivity and between-run precision claims.
- Root cause
- Other
- Status
- Terminated
- Product code
- NHG
- Quantity affected
- 6051
- Distribution
- Nationwide.
- Date initiated
- 2007-05-15
- Date posted
- 2007-06-28
- Date terminated
- 2008-06-11
- Location
- Indianapolis, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE (K043175) | Roche Diagnostics Corp. | 2004-11-24 |