Lower riskMedical device recall · FDA · Published April 30, 2018
Polymedco PATHFAST Myoglobin II Cartridge Recall: Leakage Risk
Polymedco recalls PATHFAST Myoglobin II reagent cartridges with a pinhole causing leakage, potentially leading to inaccurate test results. Affected units may have measurement errors up to +20%.
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.
Take action
Contact the company
📍Recalling firmPolymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc510 Furnace Dock Rd · Cortlandt Manor, NY 10567-6220
“Polymedco PATHFAST Myoglobin II Cartridge Recall: Leakage Risk.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71262-polymedco-pathfast-myoglobin-ii-cartridge-recall-leakage-risk. Based on FDA recall #Z-3185-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3185-2018%22&limit=1).
The FDA announced on April 30, 2018, that Polymedco, Inc. voluntarily recalled PATHFAST Myoglobin II reagent cartridges due to a pinhole hazard that may cause leakage and inaccurate test results. The agency issued recall number Z-3185-2018 for the Class II device.
How to tell if you have it
Brand: Polymedco
Product: PATHFAST Myoglobin II reagent cartridge / PATHFAST NTproBNP
Catalog Number: PF1111-K
Lot Code: T738
Expiration Date: 6/30/2018
UPC: 04987595301230
Distribution: AR, CA, FL, ID, LA, MN, NY and TX
The hazard
A pinhole caused by the laser printer in the aluminum sheet over the ALP reagent wells may cause leakage through the pinhole. If a cartridge with leakage is used, higher measurement values with a bias as low as +12% and no higher than +20% may be obtained.
Context
GovInfoNow's records show Polymedco has two other recalls on record since October 6, 2025, including a August 25, 2026 recall of SEDIPLAST Diagnostic Tubes for blood exposure risk and an October 6, 2025 recall of OC-Auto FOBT-CHEK Negative Controls for incorrect expiration date labeling. Other recent recalls of similar products include Milestone Vacuum Bag SU Large Specimen Container Recall (March 9, 2026) and Siemens Dimension Tacrolimus Flex Reagent Cartridge Recall (May 7, 2026).
How to tell if you have this one
Check for the catalog number PF1111-K on the cartridge. The affected lot is T738, which expires June 30, 2018.
Brand
Polymedco
Product
Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc recalls PATHFAST Myoglobin II reagent cartridge Catalog Number: PF1111-K PATHFAST¿ NTproBNP is a…
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
US Distribution to states of: AR, CA, FL, ID, LA, MN, NY and TX.
Recall number
Product, codes & lots
Z-3185-2018
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.; Lot T738 Exp: 6/30/2018 UDI: (01)04987595301230(17)180630(10)T738
Z-3186-2018
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.; Lot : A735 Exp: 10/31/2018 UDI: (01)04987595301636(17)181031(10)A735 and Lot: O736 Exp: 01/03/2019 UDI: (01)04987595301636(17)190131(10)O736
Based on the official FDA remedy
What to do — step by step
Check Cartridge for Pinhole
Inspect the cartridge for a pinhole in the aluminum sheet over the reagent wells.
Where it went and when
Where it was distributed
Distributed in 8 states.
Listed by the agency
Not listed
FDA distribution: “US Distribution to states of: AR, CA, FL, ID, LA, MN, NY and TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arkansas, California, Florida, Idaho, Louisiana, Minnesota, New York, Texas.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-3185-2018 (April 30, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3185-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.