medical Class II Updated 2021-12-08

Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista 500- In-vitro diagnostic device intended to

Recalled 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)

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All software versions prior to 3.10.2. GTIN: 00630414949581 and 00630414989556 (GTIN + Instrument Serial Number = Unique Device Identification (UDI)
View official government recall

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