Phadia recalls specific EliA dsDNA Well kits for potential false positive results in lupus testing. Affected kits may give inaccurate results for systemic lupus diagnosis.
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).
Phadia is recalling certain EliA ds:DNA Well kits that could cause false positive results in systemic lupus erythematosus (SLE) testing. This means test results might incorrectly indicate lupus when it's not present.
The recalled kits may produce false positive results for SLE when used with the specific lot numbers. This could lead to unnecessary concern or treatment decisions if the test shows lupus when it's not present.
People using the specific EliA dsDNA Well kits for lupus testing are affected. Those with SLE who rely on these tests for diagnosis are most at risk.
Check for the lot number 0142 on the kit label. The product was sold with the carrier lot number BFA3Y and material number 14-5500-01.
Look for the lot number 0142 on the kit label to identify affected units.
The kit may produce false positive results for systemic lupus erythematosus, meaning it could indicate lupus when it's not present.
Check for the lot number 0142 on the kit label. The product was sold with carrier lot number BFA3Y and material number 14-5500-01.
No action is required beyond checking the lot number. The recall does not require stopping use.
We’ve drafted a message you can send Phadia to request your refund or repair — edit it as you like.
Subject: Recall Z-1107-2021 — Phadia Phadia Hello, I own a Phadia that is covered by recall Z-1107-2021 from Phadia. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
