CLASS II ONGOING Device recall · Reported 22 Jan 2025 · FDA Enforcement Report
Panther Fusion GBS Assay recalled by Hologic
Hologic is recalling Panther Fusion GBS Assay, distributed in 20 states. The recall was initiated on 13 Dec 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0907-2025
- FDA event ID
- 95948
- Recalling firm
- Hologic, San Diego, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 Dec 2024
- FDA classified
- 14 Jan 2025
- Reported
- 22 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 13 Dec 2024 | Recall initiated by company | |
| 14 Jan 2025 | Classified by FDA | +32 days |
| 22 Jan 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.
Where it was distributed
AR, CA, CT, FL, IN, KS, LA, MA, ME, MI, NC, NJ, NV, NY, PR, TX, UT, VT, WA, WV, and Canada.
ArkansasCaliforniaConnecticutFloridaIndianaKansasLouisianaMassachusettsMaineMichiganNorth CarolinaNew JerseyNevadaNew YorkPuerto RicoTexasUtahVermontWashingtonWest Virginia
Questions about this recall
Why was it recalled?
Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment.
Which lots are affected?
UDI-DI: 15420045510890, Kit Lot 715927, containing Cartridge Lot 624907, Exp. Date 2025-08-15.
Where was it sold?
AR, CA, CT, FL, IN, KS, LA, MA, ME, MI, NC, NJ, NV, NY, PR, TX, UT, VT, WA, WV, and Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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