ProterixBio recalls SARS-CoV-2 IgG antibody tests and dried blood spot kits due to potential false results. Users should verify test accuracy with clinical data.
FDA review concluded that the test is insufficiently supported by clinical performance data, and results reported may not have been accurate (false positives or false negatives).
ProterixBio is recalling its SARS-CoV-2 IgG antibody tests and dried blood spot collection kits because the FDA found the tests may not work correctly, leading to false positive or negative results. This means the tests might not accurately show if someone has been infected with the coronavirus.
The test may produce false results because it lacks sufficient clinical evidence to confirm accuracy. This means the test could incorrectly indicate someone has coronavirus antibodies when they don't, or vice versa, leading to incorrect health decisions.
Anyone who purchased or used the ProterixBio SARS-CoV-2 IgG antibody test or dried blood spot kit. People most at risk are those relying on these tests for accurate coronavirus infection status.
The product includes the ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test and associated dried blood spot collection kit. No model number is listed, and all lots were recalled without specific coding.
Look for the ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test or dried blood spot kit without a model number.
The FDA found the test lacks sufficient clinical performance data, so results may not be accurate, leading to false positives or negatives.
No specific stop-use instruction is given; the recall is for verification and potential replacement.
The product has no model number and includes the ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test and dried blood spot kit.
We’ve drafted a message you can send ProterixBio to request your refund or repair — edit it as you like.
Subject: Recall Z-1058-2022 — ProterixBio ProterixBio Hello, I own a ProterixBio that is covered by recall Z-1058-2022 from ProterixBio. 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.
