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FDAFebruary 26, 2021device

Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancillary consumable to the Panther Fusion System that is used to contain the PCR and RT-PCR steps of the assay processing.

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

The hazard

There is a potential for tube trays to leak which could potentially result in false positive results, false negative results or invalid patient results.

What to do

FDA enforcement status: Ongoing

Brands named

hologic

Recall history

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

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Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancillary consumable to the Panther Fusion System that is used to contain the PCR and RT-PCR steps of the assay processing. — Recall Details · AllClear