FDA Enforcement
Class II
Terminated
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: Z-3185-2018
·
Reported September 26, 2018
Enforcement
- Recall Number
- Z-3185-2018
- Event ID
- 80724
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- September 26, 2018
- Initiation Date
- April 30, 2018
- Classification Date
- September 17, 2018
- Termination Date
- April 17, 2019
- Address
- 510 Furnace Dock Rd, N/A, Cortlandt Manor, NY, 10567-6220, United States
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.
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 Info
Lot T738 Exp: 6/30/2018 UDI: (01)04987595301230(17)180630(10)T738
Distribution
US Distribution to states of: AR, CA, FL, ID, LA, MN, NY and TX.
Quantity
272 KITS in total