Roche/Hitachi Tina-quant RF II; catalog # 3004902
FDA device recall Z-1030-03 · posted 2003-07-19 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- Test results may exhibit a positive bias when plasma samples are used for the assay.
- Action taken
- A reagent bulletin dated 9/30/02 was sent to all users. Customers were instructed to discontinue the use of plasma samples with this reagent.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 480
- Distribution
- United States
- Date initiated
- 2002-09-30
- Date posted
- 2003-07-19
- Date terminated
- 2003-07-18
- 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 |
|---|---|---|
| TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM (K002609) | Roche Diagnostics Corp. | 2000-09-05 |