Date Initiated by Firm | April 30, 2018 |
Create Date | September 17, 2018 |
Recall Status1 |
Terminated 3 on April 17, 2019 |
Recall Number | Z-3186-2018 |
Recall Event ID |
80724 |
510(K)Number | K072189 |
Product Classification |
Test,natriuretic peptide - Product Code NBC
|
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. |
Code Information |
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 |
Recalling Firm/ Manufacturer |
Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc 510 Furnace Dock Rd Cortlandt Manor NY 10567-6220
|
For Additional Information Contact | SAME 914-739-5400 |
Manufacturer 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 2 | 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 in Commerce | 272 KITS in total |
Distribution | US Distribution to states of: AR, CA, FL, ID, LA, MN, NY and TX. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = NBC
|