FDAAugust 19, 2025device

Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Description: Greiner VACUETTE Blood Collection Tube with Clot Activator and Gel Separator and Standard Stopper (16 x 100 mm, 8ml)

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

The hazard

Some of the Vacuette¿ CAT Serum Separator Clot Activator tubes were manufactured without gel separator, which could yield erroneous assay results and require the patient to return to the lab for recollection or repeat testing. This may result in delayed diagnosis, cause a delay in clinical decision-making or treatment and in some rare cases, yield incorrect results from less stable parameters.

What to do

FDA enforcement status: Ongoing

Brands named

greiner bio one north americagreinergreiner bio

UPCs

29120017573061

Recall history

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

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