Panther Fusion GBS Assay Kits with Weak Cartridge Seals May Produce Invalid Results
Hologic is recalling 380 Panther Fusion GBS Assay Kits due to potential weak pouch seals on the reagent cartridge. The seals may allow invalid or incorrect test results, potentially delaying necessary treatment.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a diagnostic device with potential to produce invalid results and delay treatment. No illnesses, injuries, or deaths have been reported. The risk to patient safety from invalid diagnostic results on a critical screening test qualifies as high severity.
Plain-English summary
Hologic, Inc. is recalling 380 Panther Fusion GBS Assay Kits (REF PRD-04484) containing Panther Fusion GBS Reagent Cartridges. These kits are used to test for Group B Streptococcus, a bacterial infection.
The recall is issued due to potential weak seals on the reagent cartridge pouches. A weak seal could allow invalid or incorrect test results, which may delay necessary treatment.
The affected kits were distributed to medical facilities in 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, and Canada. The recalled kits are identified by Kit Lot 715927 containing Cartridge Lot 624907, with an expiration date of August 15, 2025 (UDI-DI: 15420045510890).
The recalled product
- Product
- Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.
- Manufacturer
- Hologic, Inc.
- Hazard
- weak-seal
- invalid-test-results
- treatment-delay
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- UDI-DI: 15420045510890
- Kit Lot 715927
- containing Cartridge Lot 624907
- Exp. Date 2025-08-15.
Distribution
Distributed in 20 states:
- AR
- CA
- CT
- FL
- IN
- KS
- LA
- MA
- ME
- MI
- NC
- NJ
- NV
- NY
- PR
- TX
- UT
- VT
- WA
- WV
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