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.

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 measuremen…

Recall #: Z-3186-2018
Affected scope: 272 KITS in total
Initiated: April 30, 2018

Compiled from official public sources by the publisher. · Updated September 2026

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Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc recalled PATHFAST NTproBNP Catalog Number: PF1061-KUS PATHFAST¿ NTproBNP is a product for in-… - a moderate-severity action.

PATHFAST NTproBNP Catalog Number: PF1061-KUS PATHFAST¿ NTproBNP is a product for in-… was recalled by Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc in September 26, 2018. Reason: A pinhole caused by the laser printer in the aluminum sheet over the ALP reagent wells caused leakage through…. Check the official notice for the remedy. Verify recall #Z-3186-2018 with the FDA Devices before acting.

The recall

Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc issued this moderate-severity FDA Devices recall-A pinhole caused by the laser printer in the aluminum sheet over the ALP reagent wells caused leakage through….

Moderate
severity level: Class II
classification: September 26, 2018
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-3186-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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.

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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-3186-2018
Date reported	September 26, 2018
Date initiated	April 30, 2018
Recalling firm	Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc
Firm location	Cortlandt Manor, NY
Affected scope	272 KITS in total
Distribution	US Distribution to states of: AR, CA, FL, ID, LA, MN, NY and TX.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-3186-2018) and product description against the item you own. Search the archive
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Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on September 26, 2018. Severity: Moderate. Recall number: Z-3186-2018.

Where was the recalled product distributed? ▼

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

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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Similar severity · nearest report date

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This recall: FDA Devices, reported September 26, 2018. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026