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.
What this means for you
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.
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