Cortlandt Manor, NY, United States
Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc recalls
1 recall recorded since 2018, most recently on 30 April 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 30 April 2018
- Terminated
- 17 April 2019
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3185-2018, Z-3186-2018
- PATHFAST Myoglobin II reagent cartridge Catalog Number: PF1111-K PATHFAST¿ NTproBNP is a product for in-vitro diagnostic use with the in vitro diagnostic system PATHFAST¿ for the quantitative measurement of N-termina
- PATHFAST NTproBNP Catalog Number: PF1061-KUS PATHFAST¿ NTproBNP is a product for in-vitro diagnostic use with the in vitro diagnostic system PATHFAST¿ for the quantitative measurement of N-terminal-pro B-type Natriu
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.