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)
Reported: December 8, 2021 Initiated: October 15, 2021 #Z-0330-2022
Product Description
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)
Reason for Recall
Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- 1407 units
- 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.
- Location
- Newark, DE
Frequently Asked Questions
What product was recalled? ▼
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). Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 1407 units.
Why was this product recalled? ▼
Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 8, 2021. Severity: Moderate. Recall number: Z-0330-2022.
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