Polymedco, Inc. / Polymedco Cancer Diagnostic Products, LLC.

United Statesfrom the FDA registration address FDA establishment FEI 1000119795

Devices: 0
Registrations: FDA
FDA recalls: 42 ongoing

No devices from this company are in the catalogue yet.

Company details

FDA FEI number: 1000119795
Address: 510 FURNACE DOCK RD., CORTLANDT MANOR, NY, 10567

FDA recalls4

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

Recalls initiated per year

2017 0
2018 2
2019 0
2020 0
2021 0
2022 0
2023 0
2024 0
2025 1
2026 1

2026
- 25 Aug 2026 Z-0107-2027 Class II Ongoing During use of an affected tube, the operator may encounter increased resistance when inserting the pipette. The resulting pressure buildup may cause the tube cap to detach or be forcibly ejected, potentially resulting in the release of blood and exposure of the operator or surrounding work area to a biological hazard (blood). Distribution: Worldwide - US Nationwide distribution in the states and territory of AK, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS,…
  Full distribution text
  Worldwide - US Nationwide distribution in the states and territory of AK, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV and the country of United Kingdom.
  Submission number: K840500
2025
- 6 Oct 2025 Z-0538-2026 Class III Ongoing 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. 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,…
  Full distribution text
  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
  Submission number: K924061
2018
- 30 Apr 2018 Z-3185-2018 Class II Terminated 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. Distribution: US Distribution to states of: AR, CA, FL, ID, LA, MN, NY and TX. Submission number: K081360
- 30 Apr 2018 Z-3186-2018 Class II Terminated 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. Distribution: US Distribution to states of: AR, CA, FL, ID, LA, MN, NY and TX. Submission number: K072189

This is an FDA establishment record without devices in deviCERTS.