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Phadia US Inc recalls EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measurement of IgG antibodies directed to dsDNA
Recalled February 17, 2021 · FDA recall Z-1107-2021 · Phadia US
Hazard
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). · FDA Class II
Units
365 kits US
Sold at
US Nationwide distribution.
Description
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).
Product
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
Manufacturer(s)
Phadia US Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →