Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mi

Recalled December 8, 2021 · FDA recall Z-0331-2022 · Siemens Healthcare Diagnostics

Hazard

Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays · FDA Class II

Units

1326 units

Sold at

Worldwide distribution - US Nationwide distribution and the countries of DE, ES, FR, IT, CA, NL, JP, PT, AU, CZ, AT, DK, SI, BE, SK, QA, SA, KR, CH.

Description

Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays

Product

Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid SMN: 10284473 (US) and 10488224 (OUS)

Manufacturer(s)

Siemens Healthcare Diagnostics, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →