Phadia Ab: Medical Device Recall in 2019 - (Recall #: Z-1907-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: May 10, 2019

Date Posted: July 10, 2019

Recall Number: Z-1907-2019

Event ID: 82979

Reason for Recall:

Potential for reporting low assay results

Status: Terminated

Product Quantity: 30 kits

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

Voluntary or Mandated:

Voluntary: Firm initiated