Hologic Panther Fusion GBS Assay Cartridges: False Negative Risk in Diagnostics
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.
Lower-risk recall
Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/60918-hologic-panther-fusion-gbs-assay-cartridges-false-negative-risk-in.
Source Summary by GovInfoNow · govinfonow.com/recall/60918-hologic-panther-fusion-gbs-assay-cartridges-false-negative-risk-in · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0877-2022
Cite this page
“Hologic Panther Fusion GBS Assay Cartridges: False Negative Risk in Diagnostics.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60918-hologic-panther-fusion-gbs-assay-cartridges-false-negative-risk-in. Based on FDA recall #Z-0877-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0877-2022%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Hologic- Category
Medical device
What to do — step by step
Check Cartridge Lot Number
Look for the lot numbers 274954, 284599, 296991, 300796, 309230, or 309353 on the cartridge.
Where it went and when
Where it was distributed
Distributed in 20 states and Puerto Rico.
FDA distribution: “US: TX, TN, NY, NV, IN, AR, CA, CT, IL, NH, PA, WA, FL, OR, WV, VA, UT, MA, NJ, MI, PR OUS: CA” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arkansas, California, Connecticut, Florida, Illinois, Indiana, Massachusetts, Michigan, Nevada, New Hampshire, New Jersey, New York, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, Virginia, Washington, West Virginia.
Recall timeline
FDA published this recall 26 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-0877-2022 (March 18, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0877-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.