Hologic recalls Panther Fusion GBS Assay REF PRD-04484 Kit due to potential weak pouch seal causing invalid test results, which may delay treatment. Affected kits have specific lot numbers and expiration dates.
Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment.
Hologic is recalling a specific GBS test kit because its pouch seal might be weak, leading to incorrect test results and possible treatment delays. This affects kits with the lot number 715927 and expiration date August 2025.
The pouch seal on the test cartridge might be weak, which could cause the test to produce invalid or incorrect results. This might lead to a delay in proper treatment for infections.
Healthcare providers using the Panther Fusion GBS Assay kit for testing are most at risk. The recall applies to kits with specific lot numbers and expiration dates.
Check for the kit lot number 71592: the kit contains a reagent cartridge with lot number 624907 and expires August 2025.
Verify the kit lot number (715927) and cartridge lot number (624907) to confirm if it's affected.
The affected kits have lot number 715927.
The kit expires on August 15, 2025.
The recall record does not specify a remedy.
We’ve drafted a message you can send Hologic to request your refund or repair — edit it as you like.
Subject: Recall Z-0907-2025 — Hologic Hologic Hello, I own a Hologic that is covered by recall Z-0907-2025 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.
