Beckman Coulter recalls Enzymatic Creatinine Reagent (CR-E 2 X 200) for possible false test results due to acetaminophen interference. Affected units 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 Enzymatic Creatinine Reagent (CR-E 2 X 200) because it may give false test results if a patient has taken too much acetaminophen. This could delay diagnosis and treatment of health issues.
The reagent may react with high levels of NAPQI, a byproduct of acetaminophen, causing false negative results. This could delay diagnosis and treatment of health conditions that require timely intervention.
People using this reagent for in vitro diagnostic tests, especially those with acetaminophen overuse. Those with medical conditions requiring frequent blood tests may be most at risk.
Check for the product name 'Enzymatic Creatinine Reagent (CR-E 2 X 200)', reference number A60298, and the unique device identifier 15099590625733. All lot numbers are affected.
Look for the product name, reference number A60298, and unique device identifier 15099590625733 on the packaging.
The reagent may cause false negative test results if a patient has taken too much acetaminophen, potentially delaying diagnosis and treatment.
The recall record does not mention a remedy or fix for this issue.
People using this reagent for in vitro diagnostic tests, especially those with acetaminophen overuse or medical conditions requiring frequent blood tests.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-1422-2020 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-1422-2020 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.
