FDA recall Z-3186-2018

Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc · Class II · device

Product

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

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

Key facts

Status
Terminated
Initiation date
2018-04-30
Report date
2018-09-26
Termination date
2019-04-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cortlandt Manor, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3186-2018