PATHFAST Myoglobin II reagent cartridge recallZ-3185-2018 · Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc · initiated Apr 30, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-3185-2018
- Status
- Terminated
- Initiated by the company
- Apr 30, 2018
- Recalling firm
- Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc
- Quantity
- 272 KITS in total
- Product code
- JHX
- FDA submissions
- K081360
- Distribution
- US Distribution to states of: AR, CA, FL, ID, LA, MN, NY and TX.
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.
Code information (models, lots, serial numbers)
Lot T738 Exp: 6/30/2018 UDI: (01)04987595301230(17)180630(10)T738
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- PATHFAST Myo-II N/APhc Corporation · Myoglobin, Antigen, Antiserum, Control1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 80724).
- Z-3186-2018 · TerminatedPATHFAST 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 measurem…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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