Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
EliA dsDNA Well - Product Usage: intended for the In-Vitro Recalled by Phadia US Inc Due to Decreased values for EliA ANA Positive Control when...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Phadia US Inc directly.
Affected Products
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
Quantity: 365 kits US
Why Was This 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).
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Phadia US Inc
Phadia US Inc has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report