Polymedco PATHFAST NTproBNP Cartridges Recalled for Measurement Bias
Polymedco is recalling 272 PATHFAST NTproBNP cartridges due to a manufacturing defect that may cause measurement values to be 12% to 20% higher than actual.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a diagnostic device where the defect leads to inaccurate measurement results (12-20% bias), which poses a risk of harm through potential misdiagnosis, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Polymedco, Inc. is recalling 272 PATHFAST NTproBNP cartridges (Catalog Number PF1061-KUS) for in-vitro diagnostic use. The recall involves two specific lots: Lot A735 (expiration 10/31/2018) and Lot O736 (expiration 01/03/2019). The affected products were distributed to laboratories in Arkansas, California, Florida, Idaho, Louisiana, Minnesota, New York, and Texas.
The recall was initiated because a pinhole caused by a laser printer in the aluminum sheet over the ALP reagent wells resulted in leakage. If a cartridge with this leakage is used, it may produce measurement values that are higher than the actual value, with a bias ranging from +12% to +20%.
Healthcare facilities and laboratories should stop using the affected cartridges and contact Polymedco for instructions on returning the product. This recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- 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…
- Hazard
- Affected units
- 272
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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