Siemens Healthcare Diagnostics, Inc.: Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral inte

Is my product affected?

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)

• UPC 00630414949581
• UPC 00630414989556

Check against the official notice below — it lists the full affected range.

What happened

Siemens Healthcare Diagnostics has recalled 1,326 Dimension Vista 500 laboratory analyzer units distributed worldwide, including throughout the United States and multiple other countries. The recall involves an incorrect default Hemolysis, Icterus or Lipemia (HIL) Index setting that affects five assays on the device. The problem impacts all software versions prior to version 3.10.2, and the affected devices can be identified by their GTINs (00630414949581 and 00630414989556) combined with instrument serial numbers.

The Dimension Vista 500 is an in-vitro diagnostic device designed to automate laboratory analytical procedures including pipetting, mixing, heating, and spectral measurement. The recall record does not specify a remedy or recommended action for consumers or healthcare facilities with affected units.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays Distribution: 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. Quantity: 1326 units Lot/code info: All software versions prior to 3.10.2. GTIN: 00630414949581 and 00630414989556 (GTIN + Instrument Serial Number = Unique Device Identification (UDI)

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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