Lower risk Medical device recall · FDA · Published October 6, 2025

Polymedco OC-Auto FOBT-CHEK Negative Controls: Incorrect Expiration Date Label

Polymedco recalls negative hemoglobin control materials for fecal occult blood tests due to incorrect expiration date labeling on product packaging.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0538-2026Medical device Polymedco ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmPOLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC510 Furnace Dock Rd · Cortlandt Manor, NY 10567-6220

✎ GovInfoNow plain-language explainer

Polymedco is recalling negative hemoglobin control materials for fecal occult blood tests because the expiration date on the packaging is incorrectly labeled as 2026-01-16 instead of 2027-01-17. This labeling error does not pose a safety risk but could lead to improper use if the user assumes the product is still valid longer than it actually is. Read more at govinfonow.com/recall/51103-polymedco-oc-auto-fobt-chek-negative-controls-incorrect-expiration-date.

Source Summary by GovInfoNow · govinfonow.com/recall/51103-polymedco-oc-auto-fobt-chek-negative-controls-incorrect-expiration-date · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0538-2026

Cite this page

“Polymedco OC-Auto FOBT-CHEK Negative Controls: Incorrect Expiration Date Label.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/51103-polymedco-oc-auto-fobt-chek-negative-controls-incorrect-expiration-date. Based on FDA recall #Z-0538-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0538-2026%22&limit=1).

The FDA announced on Oct. 6, 2025, that Polymedco is recalling OC-Auto FOBT-CHEK Negative Controls due to a labeling error stating an incorrect expiration date of Jan. 16, 2026. The correct expiration date is Jan. 17, 2027.

How to tell if you have it

Brand: Polymedco
Product: OC-Auto FOBT-CHEK Negative Controls
Catalog Number: OCQN
Lot Number: Lot 250805
UDI: 00855574005520

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.

Context

GovInfoNow's records show Polymedco has one other recall on record since April 30, 2018, involving a leakage risk in PATHFAST Myoglobin II Cartridges. Other recent recalls of similar products include Cardinal Health ChemoPlus Gowns Recall (Nov. 12, 2025), BD Ready-to-Use Hydrophilic Catheter 14 Fr (Nov. 29, 2025), and B Braun Discofix Four Way Stopcock Recall (Aug. 4, 2026).

How to tell if you have this one

Check for the product name 'OC-Auto FOBT-CHEK Negative Controls' with the unique identifier UDI: 00855574005520 and catalog number OCQN. Lot number 250805 is also associated with this recall.

Brand
Polymedco
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Expiration Date
Verify the expiration date on the product packaging and vial labels to ensure it matches the correct date of 2027-01-17.

Where it went and when

Where it was distributed

Distributed in 46 states and D.C., and outside the U.S.

FDA distribution: “USA: AK AL,AR,AZ, CA,CO,CT,DC,DE,FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, ,WI, WV, WY, Canada: AB, ON” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Missouri, Montana, Nebraska, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 51 days after the firm started it.

Oct 6, 2025Firm started the recall
Nov 17, 2025FDA classified it Class III
Nov 26, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/51103-polymedco-oc-auto-fobt-chek-negative-controls-incorrect-expiration-date">Polymedco OC-Auto FOBT-CHEK Negative Controls: Incorrect Expiration Date Label (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0538-2026 (October 6, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0538-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.