Empowered Diagnostics recalls all ImmunoPass COVID-19 Neutralizing Antibody Test kits (NAB 900-60) sold without FDA approval. These unapproved tests pose risks of inaccurate results and potential health impacts.
COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA.
Empowered Diagnostics is recalling all ImmunoPass COVID-19 Neutralizing Antibody Test kits (NAB 900-60) because they were sold without FDA approval. Using these unapproved tests could lead to inaccurate results and potential health risks.
These test kits were distributed without FDA approval, meaning they haven't been tested for safety and accuracy. Using unapproved tests could lead to false results, which might cause unnecessary health anxiety or missed diagnoses.
Anyone who purchased or used the ImmunoPass COVID-19 Neutralizing Antibody Test kits (NAB 900-60) in the U.S. are affected. People who relied on these tests for accurate results are at risk of incorrect health assessments.
Check for the ImmunoPass brand and model NAB 900-60 on the test kit packaging. All lots of this product were recalled, so any kit purchased in the U.S. is affected.
Look for the ImmunoPass brand and model NAB 900-60 on the test kit packaging to confirm if it's recalled.
The recall record states these kits were sold without FDA approval, so they may not be safe or accurate. The official notice does not specify if they are safe to use.
The recall record does not mention any remedy or refund process, so there is no information on how to get a refund or replacement.
The recall record does not specify a remedy that requires stopping use, so the official notice does not indicate that users should stop using these tests.
We’ve drafted a message you can send Empowered Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-0481-2022 — Empowered Diagnostics Empowered Diagnostics Hello, I own a Empowered Diagnostics that is covered by recall Z-0481-2022 from Empowered Diagnostics. 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.
