# FDA recall Z-3185-2018

> **Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc** · Class II · device recall initiated 2018-04-30.

## Product

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.

## 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.

## Distribution

US Distribution to states of: AR, CA, FL, ID, LA, MN, NY and TX.

## Key facts

- **Recall number:** Z-3185-2018
- **Recalling firm:** Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-04-30
- **Report date:** 2018-09-26
- **Termination date:** 2019-04-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cortlandt Manor, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3185-2018

## Citation

> AI Analytics. FDA recall Z-3185-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-3185-2018. Source: US FDA. Licensed CC0.

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