Roche Diagnostics Corp.
Roche/Hitachi Tina-quant RF II; catalog # 3004902
| Date | Jul 19, 2003 (initiated Sep 30, 2002) |
| Status | Terminated |
| Reason | Test results may exhibit a positive bias when plasma samples are used for the assay. |
| Root cause | Other |
| Action | 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. |
| Quantity | 480 |
| Distribution | United States |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002609 | TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM Roche Diagnostics Corp., Sep 5, 2000 |