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Dimension® CSA Flex® reagent cartridge
Siemens Healthcare Diagnostics Inc. · Model 10285193 · UDI-DI 00842768025136
1
510(k) clearances
234
Adverse events
5
Recalls
10
Facilities
Description
Cyclosporine Flex® reagent cartridge, 80 tests
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-01-02 | Siemens Healthcare Diagnostics, Inc. | The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA C |
| 2014-03-19 | Siemens Healthcare Diagnostics, Inc. | A complaint was received of Dimension Vista CSA and CSAE under-recovery of cyclosporine when patient samples are run from the Small Sample Container. The under-recovery that has be |
| 2013-12-05 | Siemens Healthcare Diagnostics, Inc. | Complaints were received regarding variability in recovery of QC and patient results with certain lots of the Dimension Vista CSA Flex reagent cartridges. |
| 2011-10-07 | Abbott Laboratories | The ARCHITECT Cyclosporine assay has the potential to generate falsely elevated or depressed results with patient samples due to precision exceeding the Package Insert claim of <15 |
| 2010-08-13 | Roche Diagnostics Operations, Inc. | The cyclosporine sample pretreatment reagent lot was assigned an incorrect expiration date. |
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