FDA Device recall Z-2922-2018
is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in human serum or plasma, of anti…
- FDA Device
- Class III
- terminated
- Published 2018-08-29
On 2018-08-29 the FDA classified a Class III recall of is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in human serum or plasma, of anti… 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-2922-2018 |
| 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 qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in human serum or plasma, of antibodies specific for the Scl-70 antigen. The test is intended to as an aid to the diagnosis of scleroderma 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: TS 1740 (kit) and TS 1743 (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-2922-2018%22
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