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POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS Recalls
3 recalls on record · September 26, 2018 to November 26, 2025 · Medical Devices
Recalls by year
18
25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
November 26, 2025Medical DevicesFDA
POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC recalls OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT (Fecal Occult
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. The correct expiration date should be 2027-01-17.
September 26, 2018Medical DevicesFDA
Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc recalls PATHFAST NTproBNP Catalog Number: PF1061-KUS PATHFAST¿ NTproBNP is a product for in-vitro diagnostic use with the i
Hazard: A pinhole caused by the laser printer in the aluminum sheet over the ALP reagent wells caused leakage through the pinhole. If the cartridge with leakage is used, higher measurement value as low as +12% and no higher than +20% bias may be obtained.
September 26, 2018Medical DevicesFDA
Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc recalls PATHFAST Myoglobin II reagent cartridge Catalog Number: PF1111-K PATHFAST¿ NTproBNP is a product for in-vitro diagno
Hazard: A pinhole caused by the laser printer in the aluminum sheet over the ALP reagent wells caused leakage through the pinhole. If the cartridge with leakage is used, higher measurement value as low as +12% and no higher than +20% bias may be obtained.