Recall Z-3186-2018 ยท NBC Test, Natriuretic Peptide
Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc
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.
| Date | Apr 30, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 272 KITS in total |
| Distribution | US Distribution to states of: AR, CA, FL, ID, LA, MN, NY and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072189 | PATHFAST NTPROBNP AND D-DIMER TESTS Mitsubishi Kagaku Iatron, Feb 5, 2008 |