EliA RF IgM Well — Class II medical device recall Z-1907-2019
Terminated recall by Phadia Ab, reported 2019-07-10, distributed nationwide. Potential for reporting low assay results
| Recall number | Z-1907-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Phadia Ab, Uppsala, N/A, Sweden |
| Recall initiated | 2019-05-10 |
| Classified | 2019-07-01 |
| Reported by FDA | 2019-07-10 |
| Terminated | 2020-06-02 |
| Distributed | Nationwide (US) |
| Quantity | 30 kits |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 07333066010854 |
| Lot numbers | 0085 |
| Model numbers | 14-5600-01 |
Product
EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is intended for the in vitro quantitative measurement of IgM class rheumatoid factor antibodies in human serum and plasma (Li-heparin and EDTA) to aid in the diagnosis of rheumatoid arthritis in conjunction with other laboratory and clinical findings. EliA RF IgM uses the EliA IgM method on the instrument Phadia 100, Phadia 250, Phadia 2500 and Phadia 5000.
Reason for recall
Potential for reporting low assay results
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1907-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.