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U.S. Department of Health and Human Services

Class 2 Device Recall PATHFAST NTproBNP

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  Class 2 Device Recall PATHFAST NTproBNP see related information
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 and Original Applicant = MITSUBISHI KAGAKU IATRON
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