FDA Medical Device Recalls (openFDA)
Hologic, Inc.: Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.
- Recall number
- Z-0907-2025
- Recalling firm
- Hologic, Inc.
- Product
- Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.
- Status
- Open, Classified
- Initiated
- 2024-12-13
- Posted
- 2025-01-14
- Terminated
- not on file
- Reason
- Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment.
- Root cause
- Process control
- Action
- 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 molecularsupport@hologic.com.
- Quantity
- 380
- Distribution
- AR, CA, CT, FL, IN, KS, LA, MA, ME, MI, NC, NJ, NV, NY, PR, TX, UT, VT, WA, WV, and Canada.
- Lot, serial or model codes
- UDI-DI: 15420045510890, Kit Lot 715927, containing Cartridge Lot 624907, Exp. Date 2025-08-15.
- 510(k) numbers
- K181156
- PMA numbers
- not on file
- Product code
- NJR
- Firm FEI
- 2024800
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28