EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measurement of IgG antibo...
FDA Recall #Z-1107-2021 — Class II — December 14, 2020
Product Description
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
Reason for Recall
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).
Recalling Firm
Phadia US Inc — Portage, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
365 kits US
Distribution
US Nationwide distribution.
Code Information
Carrier Lot Number: BFA3Y; Kit Lot Number: 0142; (UDI): 07333066019406
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated