FDA Device recall Z-1907-2019
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 rheum…
- FDA Device
- Class II
- terminated
- Published 2019-07-10
On 2019-07-10 the FDA classified a Class II recall of 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 rheum… by Phadia Ab, citing potential for reporting low assay results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1907-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-05-10 |
| Published | 2019-07-10 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Phadia Ab |
| Distribution | US |
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
Potential for reporting low assay results
Identifiers
| code_info | UDI (01) 07333066010854 (17) 200630 (10) 0085 Lot Number - 0085 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1907-2019%22
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