Reported Nov 26, 2025 · Ongoing

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

Polymedco, Inc. / Polymedco Cancer Diagnostic Products, LLC

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC · 510 Furnace Dock Rd · Cortlandt Manor, NY · 10567-6220

Is this the product you have?

  • OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT (Fecal Occult Blood Test)
Lot codes and dates
  • UDI00855574005520
  • Catalog Number(s)OCQN
  • Lot Number(s)Lot 250805
Amount recalled
403 units

Where it was sold

Why it was recalled

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.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 3:38 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.