FDA Device recall Z-2918-2018
Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semiquantitative determination of IgG antibo…
- FDA Device
- Class II
- terminated
- Published 2018-08-29
On 2018-08-29 the FDA classified a Class II recall of Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semiquantitative determination of IgG antibo… by Euro Diagnostica Ab, citing decreasing performance overtime.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2918-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-14 |
| Published | 2018-08-29 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Euro Diagnostica Ab |
| Distribution | MN, TX |
Product
Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semiquantitative determination of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera.
Reason
Decreasing performance overtime.
Identifiers
| code_info | Lot # RS 3092, SS 1737 |
|---|
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-2918-2018%22
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