Recall Z-3185-2018— Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc
Class II · Terminated
Class II FDA medical device recall by Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc, initiated 2018-04-30, terminated 2019-04-17. It names one FDA 510(k) clearance: K081360. 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.. 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..
- Recalling firm
- Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-04-30
- Terminated
- 2019-04-17
- Firm location
- Cortlandt Manor, NY, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.