CLASS III ONGOING Device recall · Reported 26 Nov 2025 · FDA Enforcement Report

OC-Auto Fobt-chek Negative Controls is the negative recalled

Polymedco, Inc. / Polymedco Cancer Diagnostic Products is recalling OC-Auto Fobt-chek Negative Controls is the negative hemoglobin control materials designed, distributed in 47 states. The recall was initiated on 6 Oct 2025 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesUDI: 00855574005520, Catalog Number(s): OCQN Lot Number(s): Lot 250805

Quantity recalled403 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0538-2026
FDA event ID: 97860
Recalling firm: Polymedco, Inc. / Polymedco Cancer Diagnostic Products, Cortlandt Manor, NY
Classification: Class III
Status: Ongoing
Recall initiated: 6 Oct 2025
FDA classified: 17 Nov 2025
Reported: 26 Nov 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Patient Monitors

Timeline

6 Oct 2025	Recall initiated by company
17 Nov 2025	Classified by FDA	+42 days
26 Nov 2025	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for 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.

Product as listed by the FDA

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

Where it was distributed

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

Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI: 00855574005520, Catalog Number(s): OCQN Lot Number(s): Lot 250805

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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26 Sep 2018Device	CLASS II	Pathfast Myoglobin II reagent cartridge recalled	Polymedco, Inc.,/Polymedco Cancer Diagnostic Products	Packaging Defects	8 states

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