Hologic recalls Panther Fusion System REF 9121010000 due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive. Affected units may need replacement.
Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive.
Hologic is recalling the Panther Fusion System REF 9121010000 because it can produce false positive results for Flu B when a sample is also SARS-CoV-2 positive. This means the test might incorrectly show influenza B infection when the person actually has SARS-CoV-2.
The system can produce false positive results for influenza B when a sample contains both influenza B and SARS-CoV-2. This means the test might incorrectly indicate an influenza B infection when the person actually has SARS-CoV-2, potentially leading to unnecessary treatment or confusion in diagnosis.
Users of the Panther Fusion System REF 9121010000 who perform nucleic acid testing. Those most at risk are healthcare professionals using the system for diagnostic testing.
Check for the Panther Fusion System REF 9121010000 with serial numbers listed in the recall notice. The system is an integrated nucleic acid testing system used for diagnostic testing.
Look for the Panther Fusion System REF 9121010000 with serial numbers listed in the recall notice.
The Panther Fusion System REF 9121010000 can produce false positive results for Flu B when a sample is also SARS-CoV-2 positive.
The recall record does not specify a remedy, so no action is required beyond checking if you have the affected model.
No, the hazard is a potential for false positive results, not a physical safety risk.
We’ve drafted a message you can send Hologic to request your refund or repair — edit it as you like.
Subject: Recall Z-0782-2024 — Hologic Hologic Hello, I own a Hologic that is covered by recall Z-0782-2024 from Hologic. 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.
