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Dimension Vista® Flex® reagent cartridge LAMBDA
Siemens Healthcare Diagnostics Products GmbH · Model 10465672 · UDI-DI 00842768024436
1
510(k) clearances
58
Adverse events
2
Recalls
18
Facilities
Description
For the quantitative measurement of immunoglobulin light chains, type lambda in human serum and plasma 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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