medical Class II Updated 2021-02-17

Phadia US Inc recalls EliA dsDNA Well - Product Usage: intended for the In-Vitro q

Recalled 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

Hazard / Issue

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).

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Carrier Lot Number: BFA3Y; Kit Lot Number: 0142; (UDI): 07333066019406
View official government recall

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