Hologic recalls Panther Fusion Extraction Reagent-S (lot 258402) due to potential false positive/negative flu test results. Affected users should contact for remedy.
Reagent component included in flu test kit may cause both high background signal in a true negative sample leading to false positive and/or false negative results. This could result in false positive and/or false negative results on patient samples or failed controls leading to invalid runs. This could result in incorrect results being reported and a delay in treatment.
Hologic is recalling Panther Fusion Extraction Reagent-S kits because a component may cause false positive or false negative flu test results. This could lead to incorrect diagnoses and delayed treatment. The recall affects specific lot numbers sold in the U.S.
The reagent component may produce high background signals in true negative samples, causing false positive or false negative results. This could lead to incorrect test outcomes and delayed treatment decisions.
Users of flu test kits containing the recalled reagent. Those with recent flu tests using the specific lot numbers are most at risk.
Check for lot numbers 258402 (reagent), 257472 (capture reagent), and 257473 (enhancer reagent) on the packaging. The product is sold as a flu test kit with UDI 15420045509214.
Reach out to Hologic for instructions on returning or replacing the reagent kits.
The reagent component may cause false positive or false negative flu test results, leading to incorrect diagnoses and delayed treatment.
Lot numbers 258402 (reagent), 257472 (capture reagent), and 257473 (enhancer reagent).
Check the packaging for the lot numbers mentioned above and the unique device identifier (UDI) 15420045509214.
We’ve drafted a message you can send Hologic to request your refund or repair — edit it as you like.
Subject: Recall Z-2163-2020 — Hologic Hologic Hello, I own a Hologic that is covered by recall Z-2163-2020 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.
