OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to moni...
FDA Recall #Z-0538-2026 — Class III — October 6, 2025
Product Description
OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT (Fecal Occult Blood Test)
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.
Recalling Firm
POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC — Cortlandt Manor, NY
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product Quantity
403 units
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
Code Information
UDI: 00855574005520, Catalog Number(s): OCQN Lot Number(s): Lot 250805
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated