Recall Z-0818-2014— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-0818-2014
Creator: U.S. Food and Drug Administration
Published: 2013-12-05

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2013-12-05, terminated 2014-08-27. It names one FDA 510(k) clearance: K062236. Product: 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: 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.
Classification: Class II
Status: Terminated
Initiated: 2013-12-05
Terminated: 2014-08-27
Firm location: Newark, DE, United States

510(k) clearances named in this recall

1 on FDA's record

K062236 — DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGEDade Behring, Inc.·cleared 2006-08-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.