Dimension Vista Cyclosporine Flex reagent cartridge an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista System. Measurements are used as an aid in the management of heart, liver, and kidney transplant patients.
Reported: January 29, 2014 Initiated: December 5, 2013 #Z-0818-2014
Product Description
Dimension Vista Cyclosporine Flex reagent cartridge an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista System. Measurements are used as an aid in the management of heart, liver, and kidney transplant patients.
Reason for Recall
Complaints were received regarding variability in recovery of QC and patient results with certain lots of the Dimension Vista CSA Flex reagent cartridges.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- 1586
- Distribution
- Worldwide Distribution - USA (nationwide) and Canada.
- Location
- Newark, DE
Frequently Asked Questions
What product was recalled? ▼
Dimension Vista Cyclosporine Flex reagent cartridge an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista System. Measurements are used as an aid in the management of heart, liver, and kidney transplant patients.. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 1586.
Why was this product recalled? ▼
Complaints were received regarding variability in recovery of QC and patient results with certain lots of the Dimension Vista CSA Flex reagent cartridges.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 29, 2014. Severity: Moderate. Recall number: Z-0818-2014.
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