Siemens recalls Dimension Vista TBIL Flex Reagent Cartridges with lot 23206BA due to potential underfilling during manufacturing, which may affect calibrator and patient results.
During manufacturing, the last three tests from the 160 test flex of lot 23206BA (wells 8 or 10) were processed on the Dimension Vista platform. There was an issue with the filling line which led to some wells to underfill in lot 23206BA. Calibrator, quality control (QC) and patient results could have been impacted.
Siemens is recalling Dimension Vista Total Bilirubin (TBIL) Flex Reagent Cartridges with lot number 23206BA because some cartridges may underfill during manufacturing. This could lead to inaccurate calibrator or patient test results if used.
During manufacturing, the filling line had issues in lot 23206BA, causing some wells to underfill. This could lead to inaccurate calibrator or patient test results if the affected cartridges are used.
Users of Dimension Vista TBIL reagent cartridges with lot 23206BA are affected. Laboratory staff and healthcare providers who use these cartridges for bilirubin testing are most at risk.
Check for lot number 23206BA on the Siemens Dimension Vista TBIL Flex Reagent Cartridge. The product has Siemens Material Number (SMN) 10445146 and UDI-DI 00842768015717.
Look for lot number 23206BA on the reagent cartridge packaging.
The recall is due to potential underfilling during manufacturing in lot 23206BA, which could affect calibrator and patient test results.
The official recall notice does not specify a remedy or action for affected cartridges.
Check for lot number 23206BA on the Siemens Dimension Vista TBIL Flex Reagent Cartridge.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-3065-2024 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-3065-2024 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.
