Siemens Healthcare recalls Dimension Vista Total Bilirubin Flex reagent cartridges that may give false high bilirubin readings for patients on eltrombopag therapy. Affected lots from 2003-2012.
Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
Siemens Healthcare is recalling Dimension Vista 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 measurements for patients on eltrombopag therapy. This could lead to incorrect treatment decisions for liver or blood disorders if the test results are used without knowing the cartridge is affected.
Patients using Dimension Vista bilirubin tests with eltrombopag therapy are most at risk. The recall affects specific lots manufactured from 2003 to 2012.
Check the lot numbers listed in the recall notice: 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, 20006AB, 19336BB, 19325AB, 19325AA, 19294BC, 19291BA, 19262BD, 19238BA, 19220AA, 19207BA, 19206BA, 19162BC, 19155AB, 19128BB, 19094BA, 19084BA, 19071AA, 19060BB.
Look for the lot numbers listed in the recall notice to determine if your cartridge is affected.
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, so check the lot numbers to see if your cartridge is affected and contact Siemens Healthcare if you need further assistance.
Patients using the Dimension Vista bilirubin tests with eltrombopag therapy are most at risk.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1541-2020 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1541-2020 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.
