FDA Device recall Z-2627-2017
DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear antibody (ANA) test is a qualitative enzyme-linked imm…
- FDA Device
- Class III
- terminated
- Published 2017-07-05
On 2017-07-05 the FDA classified a Class III recall of DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear antibody (ANA) test is a qualitative enzyme-linked imm… by Euro Diagnostica Ab, citing 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 refere….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2627-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-05-22 |
| Published | 2017-07-05 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Euro Diagnostica Ab |
| Distribution | MN, NE, PA, TX |
Product
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.
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.
Identifiers
| code_info | TS 3577 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2627-2017%22
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