Device 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.
Z-3185-2018
Product summary
- Event
- Event 80724
- Status
- Terminated
- Classification
- Class II
- Quantity
- 272 KITS in total
- Official record key
device-enforcement:Z-3185-2018
Official wording
Reason: 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.
Code information: Lot T738 Exp: 6/30/2018 UDI: (01)04987595301230(17)180630(10)T738
Distribution pattern: US Distribution to states of: AR, CA, FL, ID, LA, MN, NY and TX.
Derived failure modes
-
Unknown
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.