Recall Z-0907-2025— Hologic, Inc.

Name: FDA recall Z-0907-2025
Creator: U.S. Food and Drug Administration
Published: 2024-12-13

Class II · Ongoing

Class II FDA medical device recall by Hologic, Inc., initiated 2024-12-13. It names one FDA 510(k) clearance: K181156. Product: Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.. 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..

Recalling firm: Hologic, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-12-13
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K181156 — Panther Fusion GBS AssayDiagenode·cleared 2018-07-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.