Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 26, 2018
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.
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc recalled PATHFAST Myoglobin II reagent cartridge Catalog Number: PF1111-K PATHFAST¿ NTproBNP i… - a moderate-severity action.
PATHFAST Myoglobin II reagent cartridge Catalog Number: PF1111-K PATHFAST¿ NTproBNP i… 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-3185-2018 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-3185-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-3185-2018) was formally reported on September 26, 2018, with the manufacturer initiating the action on April 30, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc is listed as the recalling firm, operating out of Cortlandt Manor, NY. Federal records list the affected scope as 272 KITS in total.
The documented reason for this recall is: 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 tha… Distribution data in the federal record shows the product reached: US Distribution to states of: AR, CA, FL, ID, LA, MN, NY and TX.. Distribution scope 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, 3 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.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
272 KITS in total
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-3185-2018 |
| 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-3185-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- 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? ▼
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.. Recalled by Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc. Units affected: 272 KITS in total.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 26, 2018. Severity: Moderate. Recall number: Z-3185-2018.
Where was the recalled product distributed? ▼
Distribution: US Distribution to states of: AR, CA, FL, ID, LA, MN, NY and TX..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-3185-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
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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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 26, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.