Siemens Healthcare recalls Atellica CH Total Bilirubin_2 assay due to potential positive bias in patients on eltrombopag therapy. This may lead to inaccurate bilirubin measurements affecting diagnosis and treatment of liver and hemolytic disorders.
Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
Siemens Healthcare is recalling its Atellica CH Total Bilirubin_2 assay for in vitro diagnostic use. The test may show falsely high bilirubin levels in patients taking eltrombopag, which could lead to incorrect medical decisions about liver or blood disorders.
The assay may produce falsely high bilirubin readings for patients taking eltrombopag. This could lead to incorrect diagnoses or treatments for liver, hemolytic, or blood disorders, especially in newborns where bilirubin levels are critical for preventing brain damage.
Patients using this bilirubin test kit while on eltrombopag therapy are most at risk. Healthcare providers who order the test for patients on this medication should check if the kit is affected.
Look for the Atellica CH Total Bilirubin_2 assay kit with lot numbers starting with 190028, 190063, 190112, 190152, 190205, 190235, or 190265. These kits were sold between April 2020 and March 2021.
Verify the lot number on the kit to see if it matches the affected numbers listed (190028, 190063, 190112, 190152, 190205, 190235, or 190265).
If you have the affected kit, inform your healthcare provider to review your bilirubin test results and consider alternative testing.
The Atellica CH Total Bilirubin_2 assay may show falsely high bilirubin levels in patients taking eltrombopag, which could lead to incorrect medical decisions.
Check the lot number on the kit. If it matches the affected numbers, contact your healthcare provider to review your test results and consider alternative testing.
No. The risk is only for patients on eltrombopag therapy, as the test may produce inaccurate results that could affect diagnosis and treatment of liver or blood disorders.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1537-2020 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1537-2020 from Siemens Healthcare. 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.
