FDAOctober 6, 2025device

OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT (Fecal Occult Blood Test)

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

The hazard

A labeling error was identified on the affected product. The expiration date on the kit box label and on the vial labels incorrectly stated the expiration date as 2026-01-16. The correct expiration date should be 2027-01-17.

What to do

FDA enforcement status: Ongoing

Brands named

polymedco inc polymedco cancer diagnostic productspolymedcopolymedco inc

UPCs

00855574005520

Recall history

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

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