Device 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.
Z-1907-2019
Product summary
- Firm
- Phadia Ab
- Event
- Event 82979
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30 kits
- Official record key
device-enforcement:Z-1907-2019
Official wording
Reason: Potential for reporting low assay results
Code information: UDI (01) 07333066010854 (17) 200630 (10) 0085 Lot Number - 0085
Distribution pattern: US Nationwide n the states of NJ, NY, MI, WV, TX including PR
Derived failure modes
-
Unknown
Potential for reporting low assay results