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DImension Vista® Protein 1 Control H (high)
Siemens Healthcare Diagnostics Products GmbH · Model 10445921 · UDI-DI 00842768006357
1
510(k) clearances
58
Adverse events
2
Recalls
18
Facilities
Description
PROT1 CON H is an assayed, high level ,intralaboratory, multi-analyte quality control for the assessment of precision and analytical bias on the Dimension Vista® System
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-05-20 | The Binding Site Group, Ltd. | The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to assigned values. |
| 2020-11-18 | The Binding Site Group, Ltd. | Due to customer complaints of positive bias impacting quality control. The high and low level controls are demonstrating a positive bias compared to assigned values. |
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