Siemens Healthcare recalls Dimension Total Bilirubin Flex reagent cartridges that may give false high bilirubin readings in patients on eltrombopag therapy. Affected lots from 2002-2008 are at risk of inaccurate test results.
Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
Siemens Healthcare is recalling Dimension Total Bilirubin Flex reagent cartridges that may show falsely high bilirubin levels in patients taking eltrombopag. This could lead to incorrect treatment decisions for liver or blood disorders.
The reagent cartridges may produce positive bias in bilirubin assays for patients taking eltrombopag. This means test results could be higher than actual levels, potentially leading to incorrect treatment decisions for liver or blood disorders.
Patients using the Dimension Total Bilirubin Flex reagent cartridges with the specific lot numbers listed in the recall notice. Those on eltrombopag therapy are most at risk of inaccurate bilirubin test results.
Check the lot numbers on the cartridge: EB1008, FA0365, FA0346, GB0326, EA0318, GD0309, FB0298, GA0284, GB0275, GD0274, FB0263, GA0256, GB0242, FD0226, EB0221, EB0192, ED0191, FC0170, FA0169, GA0157, BB0134, GB0122, GA0121, GD0113, GD0093, GD0086, FB0067, GB0059, EA0045. These lots were sold from 2002 to 2008.
Look for the lot numbers listed in the recall notice on the reagent cartridge.
The reagent cartridges may show falsely high bilirubin levels in patients taking eltrombopag therapy, which could lead to incorrect treatment decisions.
The recall notice does not specify a remedy. Check the lot number on the cartridge to see if it is affected.
This recall involves a potential for inaccurate test results, not physical harm. The risk is low and only affects patients on eltrombopag therapy.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1540-2020 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1540-2020 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.
