Dimension Vista Tbil Flex Reagent Cartridge, and Dimension Vista Tbil/Dbil Calibrator; Models K1167, KC212

• • Ongoing Z-3065-2024 FDA Class II ·initiated 30 Jul 2024

  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.

• • Terminated Z-1541-2020 FDA Class II ·initiated 13 Feb 2020

  Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy

510(k) Number

K061719 ↗

FDA Product Code

CIG

Models / Variants

Dimension Vista Tbil Flex Reagent Cartridge, And Dimension Vista Tbil/Dbil Calibrator

Models K1167, KC212

Device Class

Class II

Regulation

21 CFR Part 862.1110

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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