Recall Z-1907-2019— Phadia Ab

Name: FDA recall Z-1907-2019
Creator: U.S. Food and Drug Administration
Published: 2019-05-10

Class II · Terminated

Class II FDA medical device recall by Phadia Ab, initiated 2019-05-10, terminated 2020-06-02. It names 2 FDA 510(k) clearances: K182747, K102673. 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: Potential for reporting low assay results.

Recalling firm: Phadia Ab
Classification: Class II
Status: Terminated
Initiated: 2019-05-10
Terminated: 2020-06-02
Firm location: Uppsala, N/A, Sweden

510(k) clearances named in this recall

2 on FDA's record

K182747 — EliA RF IgM ImmunoassayPhadia AB·cleared 2018-12-18
K102673 — RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEMPhadia US, Inc.·cleared 2011-09-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

Potential for reporting low assay results

Data sourced from openFDA. This site is unofficial and independent of the FDA.