Siemens Healthcare recalls Atellica CH Direct Bilirubin_2 assay due to potential positive bias in patients on eltrombopag therapy. Affected units have specific lot numbers and were sold in 2005-2020.
Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
Siemens Healthcare is recalling its Atellica CH Direct Bilirubin_2 assay for in vitro diagnostics. This test may give falsely high bilirubin readings in patients taking eltrombopag, a medication for blood disorders. Using the test without correction could lead to incorrect liver function diagnoses.
The assay may produce falsely high bilirubin results when patients are taking eltrombopag. This could lead to incorrect diagnoses of liver problems or jaundice. The risk is specific to patients on this medication and does not affect all users.
Patients using this blood test for liver function or jaundice diagnosis who are on eltrombopag therapy. Those with the specific lot numbers listed in the recall are most at risk.
Check the lot numbers on the test kit: 190273, 190187, or 190120. These were sold between 2005 and 2020. The product is used with Siemens ADVIA Chemistry systems for bilirubin testing.
Look for the lot numbers 190273, 190187, or 190120 on the test kit packaging.
The test may give falsely high bilirubin readings in patients taking eltrombopag therapy, which could lead to incorrect liver function diagnoses.
No, but patients on eltrombopag therapy should verify results with their doctor if they receive a high bilirubin reading.
Lot numbers 190273, 190187, and 190120 were sold between 2005 and 2020.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1536-2020 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1536-2020 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
