Siemens Healthcare Diagnostics, Inc.: Dimension Vista 1500 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 1500 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: 10444801(US) and 10444802 (OUS)

• UPC 00630414949741
• UPC 00630414945460

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

What happened

Siemens Healthcare Diagnostics has recalled 1,407 units of its Dimension Vista 1500 in-vitro diagnostic device due to an incorrect default Hemolysis, Icterus or Lipemia (HIL) Index for five assays. The affected devices have all software versions prior to 3.10.2 and were distributed worldwide, including throughout the United States and in countries such as Germany, Spain, France, Italy, Canada, the Netherlands, Japan, Portugal, Australia, Czech Republic, Austria, Denmark, Slovenia, Belgium, Slovakia, Qatar, Saudi Arabia, South Korea, and Switzerland.

The HIL Index is used to identify and flag samples that may produce inaccurate test results due to hemolysis, icterus, or lipemia. The recall affects devices identified by GTIN numbers 00630414949741 and 00630414945460 combined with the instrument serial number. The source does not specify a remedy for affected consumers.

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: 1407 units Lot/code info: All software versions prior to 3.10.2. GTIN: 00630414949741 and 00630414945460 (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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