medical Class II Updated 2018-09-26

Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc recalls PATHFAST Myoglobin II reagent cartridge Catalog Number: PF1

Recalled Product

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.


Hazard / Issue

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.

Issued by

FDA

Affected States: AR, CA, FL, ID, LA, MN, NY, TX
Lot/Code Info: Lot T738 Exp: 6/30/2018 UDI: (01)04987595301230(17)180630(10)T738
View official government recall

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