FDA Device recall Z-2920-2018
is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the ph…
- 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 IgG and IgM autoantibodies specific for the ph… 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-2920-2018 |
| 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 IgG and IgM autoantibodies specific for the phospholipid cardiolipin in human serum and EDTA, lithium heparin or citrated plasma. It is intended to assess of anti-cardiolipin IgG autoantibody levels in patients where this information is useful in diagnosis, particularly in the assessment of thrombotic risk in patients with systemic lupus erythematosus, or other lupus-like disorders
Reason
Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
Identifiers
| code_info | Lot #'s: TS 2783 (kit) and TS 2787 (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-2920-2018%22
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