Z-0907-2025Class II

Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD

Name: Z-0907-2025 Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD
Creator: Hologic, Inc.
Published: 2024-12-13
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2024-12-13 / Open, Classified / root cause: manufacturing process

FDA source

Hologic, Inc. began a recall of Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD on 2024-12-13. FDA classified it as Class II and gives the reason as "Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0907-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-12-13
Posted: 2025-01-14
Recalling firm: Hologic, Inc.
Product: Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.
Product code: NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
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.
Root cause tag: manufacturing process
FDA 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 [email protected].
Quantity in commerce: 380
Distribution: AR, CA, CT, FL, IN, KS, LA, MA, ME, MI, NC, NJ, NV, NY, PR, TX, UT, VT, WA, WV, and Canada.
Product codes and lots: UDI-DI: 15420045510890, Kit Lot 715927, containing Cartridge Lot 624907, Exp. Date 2025-08-15.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0907-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0907-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-22	2025-01-14

Product code NJR

K181156Class IPanther Fusion GBS AssayDiagenode / cleared 2018-07-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)