PATHFAST Myoglobin II reagent cartridge Catalog Number: PF1111-K… — Class II medical device recall Z-3185-2018

Terminated recall by Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc, reported 2018-09-26, distributed in AR, CA, FL, ID, LA, MN, NY, TX. A pinhole caused by the laser printer in the aluminum sheet over the ALP reagent wells caused leakage through

Recall number	`Z-3185-2018`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc, Cortlandt Manor, NY, United States
Recall initiated	2018-04-30
Classified	2018-09-17
Reported by FDA	2018-09-26
Terminated	2019-04-17
Distributed	AR, CA, FL, ID, LA, MN, NY, TX
Quantity	272 kits
Reason classes	packaging
UPC / GTIN / UDI-DI	`04987595301230`
Lot numbers	`T738`
Model numbers	`PF1111-K`
Expiration dates	`2018-06-30`

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3185-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.