Recall Z-3186-2018
Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc · initiated April 30, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
PATHFAST NTproBNP Catalog Number: PF1061-KUS 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.
Codes / lots: Lot : A735 Exp: 10/31/2018 UDI: (01)04987595301636(17)181031(10)A735 and Lot: O736 Exp: 01/03/2019 UDI: (01)04987595301636(17)190131(10)O736
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.
FDA-determined 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.
Details
- Recall number
- Z-3186-2018
- Initiated
- April 30, 2018
- Terminated
- April 17, 2019
- Product code
- NBC – Test, Natriuretic Peptide
- Quantity
- 272 KITS in total
- Distribution
- US Distribution to states of: AR, CA, FL, ID, LA, MN, NY and TX.
- Recalling firm
- Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc, Cortlandt Manor, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-3185-2018 Class II | PATHFAST Myoglobin II reagent cartridge Catalog Number: PF1111-K PATHFAST NTproBNP is a…A pinhole caused by the laser printer in the aluminum sheet over the ALP reagent wells caused leakage… | 04/30/2018Terminated |