FDAAugust 17, 2022device

Fungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan in Serum Ref: FT007

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

The hazard

Incorrect information on the Fungitell STAT clamshells containing the Fungitell STAT Standard, relates to printed information for reconstitution and pretreatment volumes

What to do

FDA enforcement status: Terminated

Brands named

associates

UPCs

00862696000227

Recall history

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

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