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.
- Recall Initiated
- April 30, 2018
- Terminated
- April 17, 2019
- Recall Number
- Z-3185-2018
- Quantity
- 272 KITS in total
- Firm Location
- Cortlandt Manor, NY
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.
Lot / Code Info
Lot T738 Exp: 6/30/2018 UDI: (01)04987595301230(17)180630(10)T738
Root Cause
Process control
Action Taken
The firm, Polymedco, initiated a recall by telephone and followed with email on 4/30/18 to inform users to inspect the reagent cartridges for evidence of leakage from the ALP well and to discard cartridges that had evidence of leakage. Polymedco will replace any affected reagent cartridges. If you have any questions, contact Polymedco Technical Support at the 1.800.431.2123 Ext 285.