Home / Recalls / Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc / Z-3186-2018

Z-3186-2018 Class II Terminated

Recalled by Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc — Cortlandt Manor, NY

Recall Details

Product Type: Devices
Report Date: September 26, 2018
Initiation Date: April 30, 2018
Termination Date: April 17, 2019
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 272 KITS in total

Product Description

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 Natriuretic Peptide (NT-proBNP) in heparinized or EDTA whole blood and plasma.

Reason for Recall

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 Pattern

US Distribution to states of: AR, CA, FL, ID, LA, MN, NY and TX.

Code Information

Lot : A735 Exp: 10/31/2018 UDI: (01)04987595301636(17)181031(10)A735 and Lot: O736 Exp: 01/03/2019 UDI: (01)04987595301636(17)190131(10)O736