Z-0818-2014Class II

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

Name: Z-0818-2014 Dimension Vista Cyclosporine Flex reagent cartridge an in vitro diagnostic test for the quantitative...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2013-12-05
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2013-12-05 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Vista Cyclosporine Flex reagent cartridge an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood... on 2013-12-05. FDA classified it as Class II and gives the reason as "Complaints were received regarding variability in recovery of QC and patient results with certain lots of the Dimension Vista CSA Flex reagent cartridges". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0818-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-05
Posted: 2014-01-23
Terminated: 2014-08-27
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: MKW Cyclosporine
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Siegmens sent an Urgent Medical Device Recall lletter dated December 2013 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use and discard any remaining inventory of the affected product. Customers were also instructed to complete the attached form and fax it to 302-631-8467. Customers were asked to retain the letter with their laboratory records, and forward the letter to any who have received the affected product. Customers with questions were instructed to contact Siemens Customer Care Center - Technical Solutions or their local Siemens technical support representative. For questions regarding this recall call 800-441-9250.
Quantity in commerce: 1586
Distribution: Worldwide Distribution - USA (nationwide) and Canada.
Product codes and lots: lots 12300BB, exp. 10-26-2013; 12318BB, exp. 11-13-2013; and 13011BB, exp. 1-11-2014.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0818-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0818-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-29	2014-01-23

Product code MKW

K062236Class IIDimension Vista Cyclosporine (Csa) Flex Reagent CartridgeDade Behring, Inc. / cleared 2006-08-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)