Panther Fusion recallZ-0907-2025 · Hologic, Inc. · initiated Dec 13, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Hologic, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Process control
What the company is doing
An Urgent Medical Device Recall Notification letter issued 12/13/2024 via Fed Ex. The letter instructs customers to discontinue use of the Panther Fusion GBS Assay kit lot 715927 containing cartridge lot 624907 and segregate and count the number of affected Panther Fusion GBS Assay kits from lot 715927 containing cartridge lot 624907. Customers are instructed to destroy the product and fill out the online Customer Response Form (CRF) indicating that the on-hand inventory of recalled Panther Fusion GBS Assay Kit has been destroyed. If you have any questions or concerns regarding this recall notification, please contact Hologic Technical Support at +1 888 484 4747 or +1 858 410 8511 during the hours of 5 am PT and 5 pm PT, or by e-mail at [email protected].
Recall details
- Recall number
- Z-0907-2025
- Status
- Open, Classified
- Initiated by the company
- Dec 13, 2024
- Posted by the FDA
- Jan 14, 2025
- Recalling firm
- Hologic, Inc.
- Quantity
- 380
- Product code
- NJR
- FDA submissions
- K181156
- Distribution
- AR, CA, CT, FL, IN, KS, LA, MA, ME, MI, NC, NJ, NV, NY, PR, TX, UT, VT, WA, WV, and Canada.
Product description
Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.
Code information (models, lots, serial numbers)
UDI-DI: 15420045510890, Kit Lot 715927, containing Cartridge Lot 624907, Exp. Date 2025-08-15.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Panther Fusion® KIT, GBS ASSAY CARTRIDGES, 96-TEST, FUSION, IVDHologic, Inc. · real time Nucleic acid amplification system2 recalls0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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