Quidel recalls Sofia SARS Antigen FIA tests that may give false positive results if viral transport media is used. Consumers should test directly from swabs without transport media.
Instructions for use in the package insert for SARS Antigen FIA test were updated to remove all references to a specific viral transport medium product as well as the use of other viral transport media. Use of the specific viral transport medium products may result in False-positive results. Directly testing from specimens (NS or NP swab) is recommended.
Quidel is recalling its Sofia SARS Antigen FIA tests because using certain viral transport media can cause false positive results. The recall is for tests that were sold with specific instructions that no longer mention these media products. This matters because false positives could lead to unnecessary testing and anxiety.
The test may show a positive result for SARS-CoV-2 when there is no actual infection if viral transport media is used. This happens because the specific viral transport media products mentioned in older instructions can cause false positives. Directly testing swabs from patients is the recommended fix.
Healthcare providers using the Sofia SARS Antigen FIA test for suspected COVID-19 patients. Those most at risk are users who follow outdated instructions involving viral transport media.
The Sofia SARS Antigen FIA test kit with model numbers 1438900EN00 (March 2020) or 1438901EN00 (May 2020).
Ensure you are using the latest version of the package insert that no longer mentions viral transport media products.
The recall is because older versions of the test instructions mentioned viral transport media products that can cause false positive results. The updated instructions now recommend testing directly from swabs without transport media.
No, you can continue using the test as long as you follow the latest instructions that do not mention viral transport media products.
The official recall does not specify a return or disposal process for the older kits. Check the current instructions for the latest version of the test.
We’ve drafted a message you can send Quidel to request your refund or repair — edit it as you like.
Subject: Recall Z-0124-2021 — Quidel Quidel Hello, I own a Quidel that is covered by recall Z-0124-2021 from Quidel. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
