Phadia US Inc recalls EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measurement of IgG antibodies directed to dsDNA…

Recall date

December 14, 2020

Source

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

Recall number

Z-1107-2021

FDA classification

Class II

Brand / firm

Phadia US Inc

Sold / distributed

US Nationwide distribution.

Why it was recalled

Decreased values for EliA ANA Positive Control when using the EliA dsDNA Well lot BFA37/0142 may potentially cause false positive results (increase in patient test 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 dsDNA Well - Product Usage: intended for the In-Vitro quantitative measurement of IgG antibodies directed to dsDNA in human serum and plasma as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE). Material Number: 14-5500-01