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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 diagno
Recalled September 26, 2018 · FDA recall Z-3185-2018 · Polymedco, Inc.,/Polymedco Cancer Diagnostic Products
Hazard
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. · FDA Class II
Units
272 KITS in total
Sold at
US Distribution to states of: AR, CA, FL, ID, LA, MN, NY and TX.
Description
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.
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.
Manufacturer(s)
Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →