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 diagnosti…

Recall date

April 30, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3185-2018

FDA classification

Class II

Brand / firm

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

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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