Hologic recalls Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay kits that may give false positive results for SARS-CoV-2. Affected kits have specific lot numbers and expiration dates.
SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.
Hologic is recalling Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay kits that might show false positive results for SARS-CoV-2. This could lead to incorrect health decisions if used for testing.
The assay kit may produce false positive results for SARS-CoV-2, meaning it might indicate an infection when there isn't one. This could cause unnecessary health concerns or actions based on incorrect results.
People who own or use the Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay kits with lot numbers 892307 or 890494 are affected. Those testing for SARS-CoV-2, flu, or RSV are most at risk.
Check for the kit lot number 892307 or cartridge lot number 890494. The expiration date is May 15, 2025, and the product is labeled as Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay.
Look for the kit lot number 892307 on the product label.
Check the cartridge lot number 890494 on the product label.
No, the recall does not require stopping use. The kit may give false positives but is not dangerous.
Contact Hologic directly to confirm if your kit is affected and get instructions.
Check for kit lot number 892307 or cartridge lot number 890494 on the label.
We’ve drafted a message you can send Hologic to request your refund or repair — edit it as you like.
Subject: Recall Z-0694-2025 — Hologic Hologic Hello, I own a Hologic that is covered by recall Z-0694-2025 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.
