Recall Z-0538-2026— POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC

Name: FDA recall Z-0538-2026
Creator: U.S. Food and Drug Administration
Published: 2025-10-06

Class III · Ongoing

Class III FDA medical device recall by POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC, initiated 2025-10-06. It names one FDA 510(k) clearance: K924061. Product: OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT (Fecal Occult Blood Test). Reason: 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
Classification: Class III
Status: Ongoing
Initiated: 2025-10-06
Firm location: Cortlandt Manor, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K924061 — CANCER ANTIGEN CONTROLPolymedco, Inc.·cleared 1993-02-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.