Z-3185-2018Class II

PATHFAST Myoglobin II reagent cartridge Catalog Number: PF1111-K PATHFAST NTproBNP is a product for in-vitro...

Name: Z-3185-2018 PATHFAST Myoglobin II reagent cartridge Catalog Number: PF1111-K PATHFAST NTproBNP is a product for in-vitro...
Creator: Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc
Published: 2018-04-30
License: https://open.fda.gov/license/

Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, LLC / initiated 2018-04-30 / Terminated / root cause: manufacturing process

FDA source

Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc began a recall of 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... on 2018-04-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3185-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-30
Posted: 2018-09-17
Terminated: 2019-04-17
Recalling firm: Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, LLC
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.
Product code: JHX Fluorometric Method, Cpk Or Isoenzymes
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Lot T738 Exp: 6/30/2018 UDI: (01)04987595301230(17)180630(10)T738

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3185-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3185-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-17
Z-3186-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-17

Product code JHX

K081360Class IIPathfast Ck-Mb-II, Pathfast Myo-IIMitsubishi Kagaku Iatron / cleared 2009-08-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)