Siemens Healthcare recalls ADVIA TBIL_2 bilirubin assay kits that may show false high results for patients on eltrombopag therapy. This could lead to incorrect liver treatment decisions. Affected kits have specific serial numbers.
Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
Siemens Healthcare is recalling certain ADVIA TBIL_2 bilirubin assay kits that may show falsely high bilirubin levels in patients taking eltrombopag. This could lead to incorrect liver treatment decisions if the test results are used without knowing the bias. The recall affects specific batch numbers of the 40mL and 70mL kits.
The bilirubin assay kits may show falsely high bilirubin levels in patients taking eltrombopag. This could lead to incorrect liver treatment decisions if the test results are used without knowing the bias. The issue is specific to certain batches and does not affect all users.
Patients using these specific bilirubin assay kits for lab testing, particularly those on eltrombopag therapy. Lab technicians and healthcare providers who use the kits are at risk of potential misdiagnosis.
Check for serial numbers starting with 492094, 486525, 478149, 472677, 469083, 462464, 455486, 452851, 447317, 436498 for 40mL kits and 492102, 492111, 486533, 478154, 478159, 493710, 490263, 490264, 469088, 469094, 462470, 462477, 455496, 455501, 452858, 452863, 452870, 447325, 447332, 436510, 436515 for 70mL kits. The kits are used in lab settings for bilirubin testing.
Look for specific serial numbers listed in the recall notice to determine if your kit is affected.
The bilirubin assay kits may show falsely high bilirubin levels in patients taking eltrombopag therapy, which could lead to incorrect liver treatment decisions.
No, the recall does not require stopping use immediately. Affected kits should be checked against the listed serial numbers.
Check the serial numbers on your kit against the list provided in the recall notice, which includes specific numbers for 40mL and 70mL kits.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1539-2020 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1539-2020 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.
