Beckman Coulter recalls Lipase test kits OSR6130 and OSR6230 due to potential NAPQI interference in overdose patients. All lots affected.
NAPQI, a metabolite of Acetaminophen, causes negative interference with the recalled product assays at levels present in the serum/plasma of overdose patients.
Beckman Coulter is recalling two lipase test kit models (OSR6130 and OSR6230) because they may give inaccurate results when used on patients with acetaminophen overdose. This could lead to incorrect medical decisions.
The test kits can be interfered with by NAPQI, a byproduct of acetaminophen overdose. This interference may cause false results in patients with high levels of NAPQI in their blood.
Patients using these lipase test kits for acetaminophen overdose screening may get inaccurate results. Healthcare providers ordering these kits are most at risk.
Check for the product names 'Beckman Coulter Lipase' with reference numbers OSR6130 or OSR6230. All lots of these products are affected.
Identify if your test kit has reference numbers OSR6130 or OSR6230.
The test kits may give inaccurate results when used on patients with acetaminophen overdose due to interference from NAPQI.
The recall covers all lots of these test kits. Check the reference numbers to confirm if your product is affected.
The official recall does not provide a remedy or fix for this issue.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-0210-2020 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-0210-2020 from Beckman Coulter. 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.
