POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC: Medical Device Recall in 2025 - (Recall #: Z-0538-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: October 6, 2025

Date Posted: November 26, 2025

Recall Number: Z-0538-2026

Event ID: 97860

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.

Status: Ongoing

Product Quantity: 403 units

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated