FDAApril 30, 2018device
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 a...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
polymedco inc polymedco cancer diagnostic productspolymedcopolymedco inc
UPCs
04987595301230
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- CPSCYamazuki Recalls Youth All-Terrain Vehicles (ATVs) Due to Risk of Serious Injury or Death from Crash; Violate Mandatory Standard for ATVs2026-06-25
- CPSCArizer Solo III Portable Vaporizers Recalled Due to Fire and Burn Hazards; Risk of Serious Injury or Death; Imported by 7111495 Canada2026-06-18
- CPSCMiniWarGaming and Primal Horizon Disc Magnets Recalled Due to Risk of Serious Injury or Death from Ingestion; Violate Mandatory Standard for Magnets; Imported by MiniWarGaming2026-05-28
- CPSCMissry Associates Recalls Misco Sports Light-Up Racket Sets Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for Toys2026-05-28
- CPSCResistance Bands Recalled Due to Serious Injury from Impact Hazard; Imported by HomeProGym2026-05-21
- FDAMedtronic O-arm O2 Imaging System. Model Number: BI70002000.2026-05-19
- FDAFarm Rich Pizza Cheese Crunchers2026-05-19
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