Phadia Ab recalls EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is intended for the in vitro quantitative measuremen…

Recall date

May 10, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1907-2019

FDA classification

Class II

Brand / firm

Phadia Ab

Sold / distributed

US Nationwide n the states of NJ, NY, MI, WV, TX including PR

Why it was recalled

Potential for reporting low assay results

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.