Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

PATHFAST Myoglobin II reagent cartridge Catalog Number: PF1111-K PATHFAST¿ NTproBNP Recalled by Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc Due to A pinhole caused by the laser printer in...

Date: April 30, 2018
Company: Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc directly.

Affected Products

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.

Quantity: 272 KITS in total

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 8 states: AR, CA, FL, ID, LA, MN, NY, TX

Affected (8 states)Not affected

About Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc

Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report