medical Class II Updated 2022-04-13

Hologic, Inc recalls Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number

Recalled Product

Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.


Hazard / Issue

Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results.

Issued by

FDA

Affected States: TX, TN, NY, NV, IN, AR, CA, CT, IL, NH, PA, WA, FL, OR, WV, VA, UT, MA, NJ, MI
Lot/Code Info: UDI: 15420045510890, Lot numbers: 274954, 284599, 296991, 300796, 309230, 309353
View official government recall

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