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Phadia Ab recalls EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is intended for the in vitro quantitative measur
Recalled July 10, 2019 · FDA recall Z-1907-2019 · Phadia Ab
Hazard
Potential for reporting low assay results · FDA Class II
Units
30 kits
Sold at
US Nationwide n the states of NJ, NY, MI, WV, TX including PR
Description
Potential for reporting low assay results
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.
Manufacturer(s)
Phadia Ab
Made in
Sweden
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →