Beckman Coulter recalls two bilirubin reagent kits that may cause false low bilirubin test results, delaying diagnosis and treatment. Affected kits have specific lot numbers and are for in vitro diagnostic use only.
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 false low bilirubin test results. This might delay diagnosis and treatment of liver conditions. The kits are for in vitro diagnostic use only and require a prescription.
The reagents may contain NAPQI, a metabolite of acetaminophen, which can interfere with bilirubin tests. This could lead to false low bilirubin readings, potentially delaying diagnosis and treatment of liver conditions.
Healthcare professionals using these reagents for blood tests may be affected. Patients receiving liver-related tests could be at risk if the reagents cause inaccurate results.
Check for the product names 'DBIL 2 x 200' (lot number 439715) or 'DBIL 2 x 300' (lot number 476856). These reagents are for in vitro diagnostic use only and require a prescription.
Identify the lot numbers on the reagent packaging to determine if it is affected (439715 or 476856).
The reagents may contain NAPQI, a metabolite of acetaminophen, which can cause false low bilirubin test results, potentially delaying diagnosis and treatment.
Check the lot numbers on the reagent packaging. If it is 439715 or 476856, contact Beckman Coulter for guidance.
The reagents are for in vitro diagnostic use only and require a prescription. They may cause false low bilirubin results if NAPQI is present in high quantities.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-1425-2020 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-1425-2020 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.
