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Open, Classified

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

FDA Recall Z-0907-2025 · Posted 2025-01-14

Recalling FirmHologic, Inc.
Recall StatusOpen, Classified
Product CodeNJR
Date Initiated2024-12-13
Product Quantity380

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.

Firm 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].

Root Cause

Process control

Distribution Pattern

AR, CA, CT, FL, IN, KS, LA, MA, ME, MI, NC, NJ, NV, NY, PR, TX, UT, VT, WA, WV, and Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K181156Panther Fusion GBS AssayDiagenode · 2018-07-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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