FDA Device recall Z-2919-2018
is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantibodies specific for Anti-Ro (SS-A) ant…
- FDA Device
- Class III
- terminated
- Published 2018-08-29
On 2018-08-29 the FDA classified a Class III recall of is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantibodies specific for Anti-Ro (SS-A) ant… by Euro Diagnostica Ab, citing incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2919-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-10-21 |
| Published | 2018-08-29 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Euro Diagnostica Ab |
| Distribution | MN |
Product
is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantibodies specific for Anti-Ro (SS-A) antigen in human serum or plasma. EDTA, lithium heparin, citrated plasma. It is intended to aid in the diagnosis of systemic rheumatic diseases, particularly Sj¿gren's syndrome and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process.
Reason
Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
Identifiers
| code_info | Lot #'s: TS2725 (kit) and TS 2733 (PC) |
|---|
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-2919-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.