Beckman Coulter recalls Triglycerides Reagent (TG 2 x 300) for in vitro diagnostic use due to potential interference with test results, which could 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 Triglycerides Reagent (TG 2 x 300) because it may cause incorrect test results if used with high acetaminophen levels in serum. This could delay diagnosis and treatment of health conditions.
The reagent may contain NAPQI, a metabolite of acetaminophen, which can interfere with test results if present in high quantities in serum. This interference could lead to incorrect test outcomes and delay proper diagnosis and treatment.
Healthcare professionals who use this reagent for in vitro diagnostic tests are affected. Patients undergoing tests that require this reagent may be at risk of delayed diagnosis if the reagent is used incorrectly.
The recalled product is Triglycerides Reagent (TG 2 x 300) with reference number 445850. It is for in vitro diagnostic use, requires a prescription, and has the unique device identifier 15099590233228. All lot numbers are affected.
Verify the product name, reference number, and unique device identifier to confirm if it matches the recalled items.
The reagent may contain NAPQI, a metabolite of acetaminophen, which can cause negative interference with test results if present in high quantities in serum, potentially delaying diagnosis and treatment.
The recall record does not specify a remedy or fix for this issue.
The recalled product is Triglycerides Reagent (TG 2 x 300) with reference number 445850, for in vitro diagnostic use, requiring a prescription, and has the unique device identifier 15099590233228. 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-1423-2020 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-1423-2020 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.
