Roche PTH (parathyroid hormone test system) for use in conjunction with Roche cobas e 411, cobas e 601, Elecsys 1010, El
FDA device recall Z-0810-2007 · posted 2007-05-16 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- Negative bias caused by hemolysis interference at the low end of the reference range could cause erroneous diagnosis of hypoparathyroidism.
- Action taken
- The firm issued a letter dated 04/19/07 to all users informing them of the change in the hemoglobin interference claim.
- Root cause
- Other
- Status
- Terminated
- Product code
- CEW
- Quantity affected
- 14,503
- Distribution
- Nationwide.
- Date initiated
- 2007-04-19
- Date posted
- 2007-05-16
- 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 PARATHYROID HORMONE TEST SYSTEM (K992680) | Roche Diagnostics Corp. | 1999-09-28 |