Polymedco recalls PATHFAST NTproBNP diagnostic kits with a laser-printing pinhole that may cause up to 20% measurement bias in blood tests. Affected lots: A735 (exp 10/31/2018) and O736 (exp 01/03/2019).
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.
Polymedco recalls PATHFAST NTproBNP diagnostic kits that may have a pinhole causing measurement errors up to 20% in blood tests. This could lead to inaccurate cancer biomarker results if used.
A pinhole in the aluminum sheet from the laser printer can cause liquid leakage. This may cause the test to show up to 20% higher results than actual, potentially leading to incorrect cancer biomarker measurements.
Users of PATHFAST NTproBNP diagnostic kits for cancer biomarker testing. Those with the specific lot numbers A735 (expiring 10/31/2018) or O736 (expiring 01/03/2019) are most at risk.
Check the lot number on the kit: A735 (expires 10/31/2018) or O736 (expires 01/03/2019). The product is for in-vitro diagnostic use with PATHFAST for measuring NT-proBNP in blood plasma.
Look for lot numbers A735 (expiring 10/31/2018) or O736 (expiring 01/03/2019) on the kit.
A pinhole in the aluminum sheet from the laser printer can cause liquid leakage, leading to up to 20% higher measurement results than actual.
Using a kit with leakage may cause the test to show up to 20% higher NT-proBNP levels than the true value, potentially leading to inaccurate cancer biomarker results.
Check the lot number on your kit. If it's A735 (expiring 10/31/2018) or O736 (expiring 01/03/2019), stop using it and contact Polymedco for instructions.
We’ve drafted a message you can send Polymedco to request your refund or repair — edit it as you like.
Subject: Recall Z-3186-2018 — Polymedco Polymedco Hello, I own a Polymedco that is covered by recall Z-3186-2018 from Polymedco. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
