Polymedco PATHFAST Myoglobin II Cartridges Recalled for Leakage
Polymedco is recalling 272 PATHFAST Myoglobin II reagent cartridges due to a pinhole defect that may cause measurement bias.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a measurement bias rather than a direct physical injury or acute health risk, fitting the Moderate criteria for low-risk contamination or minor defects.
Plain-English summary
Polymedco, Inc. is recalling 272 PATHFAST Myoglobin II reagent cartridges (Catalog Number: PF1111-K, Lot T738, Exp: 6/30/2018). The recall is due to a pinhole in the aluminum sheet over the ALP reagent wells, caused by the laser printer, which resulted in leakage.
The affected cartridges were distributed to laboratories in Arkansas, California, Florida, Idaho, Louisiana, Minnesota, New York, and Texas. If a leaking cartridge is used, it may produce measurement values with a bias as low as +12% and no higher than +20%.
Users should stop using the affected cartridges and contact Polymedco for instructions on return or replacement.
The recalled product
- 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…
- Hazard
- Affected units
- 272
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot T738 Exp: 6/30/2018 UDI: (01)04987595301230(17)180630(10)T738
Distribution
Part of a larger recall action
This product is one of 2 recalled by Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc
See all →- SeverePolymedco Sediplast Tubes Recalled for Potential Blood Exposure
FDA (Devices) · 2026-10-14
- LowFecal occult blood controls recalled over a wrong expiration date printed
FDA (Devices) · 2025-11-26
- HighPolymedco PATHFAST NTproBNP Cartridges Recalled for Measurement Bias
FDA (Devices) · 2018-09-26
Same hazard · measurement bias
See all →- HighEmano Flow Uroflowmetry App Recalled Over Biased Flow Estimates
FDA (Devices) · 2026-07-29
- HighStago D-dimer assay shows positive bias across entire analytical range
FDA (Devices) · 2026-03-25
- HighCapillary tubes recalled over a positive bias in potassium results
FDA (Devices) · 2026-02-25
- HighVITROS Chemistry CRP Diagnostic Slides May Underreport Elevated Results
FDA (Devices) · 2024-12-04
- Highepoc BGEM BUN Test Cards recalled for sodium measurement bias
FDA (Devices) · 2024-11-13
Similar recalls
- SevereVentana Medical Systems Recalls Leaking CINtec p16 Histology Reagent Dispensers
FDA (Devices) · 2018-09-26
- HighSiemens Recalls Dimension Vista B2-Microglobulin Reagent Cartridges
FDA (Devices) · 2015-09-02
- SevereVentana CONFIRM anti-Progesterone Receptor Antibody Recalled for Dispenser Defects
FDA (Devices) · 2018-09-26
- HighOrtho-Clinical Diagnostics Recalls VITROS NT-proBNP Reagent for Biased Results
FDA (Devices) · 2019-01-09
- SevereVentana anti-Helicobacter Pylori Reagent Recall Due to Dispenser Leaks
FDA (Devices) · 2018-09-26
- SevereVentana Medical Systems Recalls Leaking HPV III Probe Dispensers
FDA (Devices) · 2018-09-26