Hologic recalls Panther Fusion GBS Assay Cartridges (96 tests) due to potential false negative results when analyte concentrations are near detection limits. Affected lots include 274954, 284599, 296991, 300796, 309230, 309353.
Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results.
Hologic is recalling Panther Fusion GBS Assay Cartridges (96 tests) because samples with analyte concentrations near the detection limit may give false negative results. This could lead to incorrect diagnoses of group B strep infections, which is serious for pregnant women and newborns.
The test may produce false negative results when analyte concentrations are very low or near the detection limit. This means group B strep infections could be missed, potentially leading to complications for the baby.
Pregnant women and newborns using the Panther Fusion GBS Assay Cartridges for group B strep testing are most at risk. The recall affects specific lots of the 96-test cartridges.
Check the catalog number PRD-04484 on the cartridge. Affected lots include 274954, 284599, 296991, 300796, 309230, and 309353. The product is an in vitro diagnostic test for group B strep.
Look for the lot numbers 274954, 284599, 296991, 300796, 309230, or 309353 on the cartridge.
The test may produce false negative results when analyte concentrations are near the detection limit, which could miss group B strep infections.
Check the lot number on the cartridge. If it matches the affected lots listed, contact Hologic for guidance.
The recall record does not mention a remedy or fix for this issue.
We’ve drafted a message you can send Hologic to request your refund or repair — edit it as you like.
Subject: Recall Z-0877-2022 — Hologic Hologic Hello, I own a Hologic that is covered by recall Z-0877-2022 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.
