FDA recall Z-1907-2019

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2019-05-10

Report date

2019-07-10

Termination date

2020-06-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Uppsala, N/A, Sweden

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1907-2019