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DImension Vista® Immunoglobulin E Flex® reagent cartridge
Siemens Healthcare Diagnostics Products GmbH · Model 10445902 · UDI-DI 00842768006173
1
510(k) clearances
40
Adverse events
3
Recalls
30
Facilities
Description
For the quantitative measurement of immunoglobulin E in human serum and plasma (heparin or EDTA) on the Dimension Vista® System
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-03-05 | Tosoh Bioscience Inc | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay. |
| 2016-09-07 | Randox Laboratories Ltd. | According to the firm, the IgE Calibrator Series IE2492 (lot 387-392IE) value assignment has now been aligned to the 3rd International Standard for human serum IgE 11/234. Turbidi |
| 2009-01-05 | Siemens Medical Solutions Diagnostics | Design Flaw: The redesign of the Digital Fluidics PCB used in IMMULITE 2000 and IMMULITE 2500 is missing a jumper. |
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