Hologic, Inc. 2025-01-22 Health serious FDA
Health · FDA · Recall #FDA-Z-0907-2025
Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent… Recall
Issued January 22, 2025 · Hologic, Inc.
In January 2025, Hologic, Inc. recalled the Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 you should do
- 1 Stop using Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Hologic, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Hologic, Inc.
- Category
- Health
- Recall date
- January 22, 2025
- Units affected
- Not reported
- Sold at
- AR, CA, CT, FL, IN, KS, LA, MA, ME, MI, NC, NJ, NV, NY, PR, TX, UT, VT, WA, WV, and Canada.
- Recall number
- FDA-Z-0907-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Hologic, Inc. has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.