FDA Medical devices recall ·
Panther Fusion GBS Assay recall
- Recall number
- Z-0907-2025
- Date
- (initiated December 13, 2024)
- Company / brand
- Hologic, Inc
10210 Genetic Center Dr, San Diego, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 380
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 15420045510890, Kit Lot 715927, containing Cartridge Lot 624907, Exp. Date 2025-08-15.
Distribution
AR, CA, CT, FL, IN, KS, LA, MA, ME, MI, NC, NJ, NV, NY, PR, TX, UT, VT, WA, WV, and Canada.
States: Arkansas California Connecticut Florida Indiana Kansas Louisiana Massachusetts Maine Michigan North Carolina New Jersey Nevada New York Puerto Rico Texas Utah Vermont Washington West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0907-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.