Recall Z-0929-2018 ยท LKJ Antinuclear Antibody, Antigen, Control
Euro Diagnostica AB
DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200. Product Usage: The DIASTAT anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl- 70, Jo-1, dsDNA, histone and centromere antigens.The test may be used to scree
| Date | Oct 15, 2015 |
| Status | Terminated |
| Reason | Complaint investigation concluded that although product quality requirements stated in the instructions for use were met at lot release, the high background in the ELISA plate, the strong IgM conjugate, and the low reference control led to an increased risk of equivocal and/or false positive sample test results for the two FANA200 kit lots SS 1500 and SS 2009. |
| Root cause | Nonconforming Material/Component |
| Action | Euro Diagnostica sent a Customer notifications letter to affected customers via email on 10/15/2015. The letter identified the affected product problem and actions to be taken. For question contact Euro Diagnostica . |
| Quantity | 1090 |
| Distribution | Worldwide Distribution and US. Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K932876 | DIASTAT ANTI-NUCLEAR ANTIBODY (ANA) KIT Shield Diagnostics, Ltd., Nov 15, 1993 |