Recall Z-2627-2017 ยท LKJ Antinuclear Antibody, Antigen, Control
Euro Diagnostica AB
DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) 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.
| Date | May 22, 2017 |
| Status | Terminated |
| Reason | FANA200 kit lot TS 3577 was re-worked due to shortened shelf-life. The alert sticker on the kit box of the lot informed customers that the shelf-life had been shortened and referenced a letter sent to customers for more information, where the new expiration date was stated. The original kit box label remained on the kit box stating the original expiration date, the packaging did not display the correct expiration date. |
| Root cause | Other |
| Action | The firm initiated the problem by email on 05/22/2017. The consignee was directed to destroy the product. |
| Quantity | 501 units |
| Distribution | MN, TX, NE, PA, Spain, Egypt, Pakistan, Nepal, Canada |
| 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 |