Beckman Coulter recalls TBIL 2 x 300 and 2 x 400 reagent kits for potential incorrect bilirubin test results due to acetaminophen interference. Affected kits may delay diagnosis and treatment.
It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may cause negative interference for assays if present in high quantities in serum due to acetaminophen overdoese. This could result in a delay in diagnosis and treatment.
Beckman Coulter is recalling two types of bilirubin reagent kits that could cause inaccurate test results if used with high acetaminophen levels in blood. This might delay proper diagnosis and treatment of liver conditions.
The reagent may interact with high levels of acetaminophen in blood, causing false low bilirubin readings. This could delay diagnosis and treatment of liver issues. The risk is only present if the person has high acetaminophen levels.
People using these reagent kits for blood tests at home or in labs. Those with liver conditions or taking acetaminophen regularly may be at higher risk.
Check for product codes: Ref:442745 (300 tests) or Ref:476861 (400 tests). All lot numbers are affected. These kits are for in vitro diagnostic use only and require a prescription.
Look for the product reference codes: 442745 (300 tests) or 476861 (400 tests).
The reagent may cause inaccurate bilirubin test results if used with high acetaminophen levels in blood, potentially delaying diagnosis and treatment.
No specific action is required. The recall is for potential inaccurate results, not immediate safety risks.
Check the product reference codes: 442745 (300 tests) or 476861 (400 tests). All lot numbers are affected.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-1426-2020 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-1426-2020 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.
