Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Panther Fusion GBS Assay Cartridges 96 Tests Recalled by Hologic, Inc Due to Samples, run on a GBS Assay, that have...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Hologic, Inc directly.
Affected Products
Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.
Quantity: 2061
Why Was This Recalled?
Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results.
Where Was This Sold?
This product was distributed to 20 states: AR, CA, CT, FL, IL, IN, MA, MI, NV, NH, NJ, NY, OR, PA, TN, TX, UT, VA, WA, WV
About Hologic, Inc
Hologic, Inc has 24 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report