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
Check against the official notice below — it lists the full affected range.
Polymedco, Inc. is recalling PATHFAST Myoglobin II reagent cartridges (Catalog Number PF1111-K, Lot T738, expiration 6/30/2018) due to pinholes caused by a laser printer in the aluminum sheet covering the ALP reagent wells. These pinholes can allow leakage from the cartridge. A total of 272 kits were distributed to Arkansas, California, Florida, Idaho, Louisiana, Minnesota, New York, and Texas.
If a leaking cartridge is used, test results may show higher measurement values with a bias ranging from 12% to 20% above the actual value. The recall notice does not specify what affected consumers should do regarding this product.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Quantity: 272 KITS in total Lot/code info: Lot T738 Exp: 6/30/2018 UDI: (01)04987595301230(17)180630(10)T738
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.