Panther Fusion GBS Assay Cartridges Recalled for False Negative Results
Hologic is recalling 2,061 Panther Fusion GBS Assay Cartridges because samples at or near the limit of detection may produce false negative results, risking missed diagnosis of group B streptococcus infection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is a risk-of-harm product where no injuries have been reported. The defect (false negative results) could lead to missed diagnosis of group B streptococcus, a serious pathogen. However, the false negatives are limited to samples at or near the limit of detection.
Plain-English summary
Hologic, Inc is recalling 2,061 Panther Fusion GBS Assay Cartridges (Catalog Number PRD-04484), in vitro diagnostic tests for detecting group B streptococcus. The recall was initiated because samples run on the GBS assay with analyte concentrations at or near the limit of detection may produce false negative results.
The affected cartridges were distributed across the United States, including Texas, Tennessee, New York, Nevada, Indiana, Arkansas, California, Connecticut, Illinois, New Hampshire, Pennsylvania, Washington, Florida, Oregon, West Virginia, Virginia, Utah, Massachusetts, New Jersey, Michigan, and Puerto Rico. Affected lot numbers include 274954, 284599, 296991, 300796, 309230, and 309353.
Healthcare providers using these cartridges should review test results and consult appropriate resources when interpreting results from samples at or near the limit of detection. Customers should contact Hologic for guidance on affected products.
The recalled product
- Product
- Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.
- Manufacturer
- Hologic, Inc
- Affected units
- 2,061
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 (7)
- UDI: 15420045510890
- Lot numbers: 274954
- 284599
- 296991
- 300796
- 309230
- 309353
Distribution
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