Official recall record

Dimension Vista® System - Total Bilirubin Assay

What the authority reported

Siemens Healthineers has confirmed, through investigation of customer complaints, the potential for discordant total bilirubin (tbil) results when the last three tests from the 160 test flex of lot 23206bA (wells 8 or 10) were processed on the Dimension Vista® platform. Calibrator, quality control and patient results could be impacted. The impact is variable across the analytical measurement range. This issue is isolated only to a portion of the flex lot therefore, the probability of occurrence of a discordant tbil result was determined to be 1%. Results could be erroneously increased or depressed due to the uncertain delivery of reagents from underfilled wells into the reaction cuvette. Recall start date: August 6, 2024

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

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