Siemens Healthcare Diagnostics, Inc. Recall: Dimension Vista 500- In-vitro diagnostic devi
Siemens Healthcare Diagnostics, Inc. Recall: Dimension Vista 500- In-vitro diagnostic devi is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Siemens Healthcare Diagnostics, Inc.; Product: Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures s
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
|---|---|
| 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) |
| Reason for recall | Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| 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. |
| Recall initiated | 20211015 |
| Recall number | Z-0331-2022 |
| Category | device |
| State | DE |
| Country | United States |
$29/mo
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