Reported Sep 26, 2018 · Terminated
PATHFAST Myoglobin II reagent cartridge Catalog Number: PF1111-K PATHFAST¿ NTproBNP is a product for in-vitro…
Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc · 510 Furnace Dock Rd · Cortlandt Manor, NY · 10567-6220
Is this the product you have?
- PATHFAST Myoglobin
- II reagent cartridge Catalog NumberPF1111-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
- Lot codes and dates
- Lot T738 Exp6/30/2018
- UDI(01)04987595301230(17)180630(10)T738
- Amount recalled
- 272 KITS in total
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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