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Dimension Vista Cyclosporine Flex reagent cartridge an in vitro diagnostic test for the quanti...

FDA Recall #Z-0818-2014 — Class II — December 5, 2013

Recall #Z-0818-2014 Date: December 5, 2013 Classification: Class II Status: Terminated

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.

Recalling Firm

Siemens Healthcare Diagnostics, Inc. — Newark, DE

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

1586

Distribution

Worldwide Distribution - USA (nationwide) and Canada.

Code Information

lots 12300BB, exp. 10-26-2013; 12318BB, exp. 11-13-2013; and 13011BB, exp. 1-11-2014.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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