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FDAMarch 18, 2022device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

hologic

UPCs

15420045510890

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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