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.
Check against the official notice below — it lists the full affected range.
Polymedco, Inc. recalled PATHFAST NTproBNP diagnostic cartridges (Catalog Number PF1061-KUS) used for in-vitro diagnostic testing. The recall involves 272 kits distributed to Arkansas, California, Florida, Idaho, Louisiana, Minnesota, New York, and Texas. A manufacturing defect caused pinholes in the aluminum sheet covering the ALP reagent wells, created by the laser printer during production. These pinholes allowed leakage that could result in measurement values 12% to 20% higher than accurate readings if affected cartridges are used.
The affected cartridges are Lot A735 (expiration 10/31/2018) and Lot O736 (expiration 01/03/2019), identified by their respective UDI numbers. The source document does not specify what actions affected consumers should take in response to this recall.
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 : A735 Exp: 10/31/2018 UDI: (01)04987595301636(17)181031(10)A735 and Lot: O736 Exp: 01/03/2019 UDI: (01)04987595301636(17)190131(10)O736
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.