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
- Recall Number
- Z-3185-2018
- Event Number
- 80724
- Firm
- Polymedco, Inc., Polymedco Cancer Diagnostic Products, Llc
- FEI Number
- 1000119795
- Product Code
- JHX
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- April 30, 2018
- Terminated
- April 17, 2019
- Address
- 510 Furnace Dock Rd, Cortlandt Manor, NY, 10567-6220
Description
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.
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.
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.
US Distribution to states of: AR, CA, FL, ID, LA, MN, NY and TX.
272 KITS in total