Z-1647-2014Class II

Dimension Vista CSA and CSAE The Cyclosporine method is an in vitro diagnostic test for the quantitative...

Name: Z-1647-2014 Dimension Vista CSA and CSAE The Cyclosporine method is an in vitro diagnostic test for the quantitative...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2014-03-19
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2014-03-19 / Terminated / root cause: design

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Vista CSA and CSAE The Cyclosporine method is an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole... on 2014-03-19. FDA classified it as Class II and gives the reason as "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 been observed is 18 to 44%. In March...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1647-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-19
Posted: 2014-05-21
Terminated: 2015-08-10
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension Vista CSA and CSAE The Cyclosporine method is an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista System. Measurements of CSA are used as an aid in the management of heart, liver and kidney transplant patients.
Product code: MKW Cyclosporine
Reason for recall: 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 been observed is 18 to 44%. In March 2014, Siemens recalled due to the complaint received of Dimension Vista CSA and CSAE reporting under-recovery of cyclosporine when patient samples are run from the Small Sample C
Root cause tag: design
FDA root cause: Device Design
Action: Siemens sent an Urgent Medical Device Correction letter dated March 2014. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed not to use the SSC with patient samples when running CSE or CSAE. Siemens also recommended a look back at previously generated CSA or CSAE results if the patient samples have been run from the SSC and that the content of this letter should be discussed with the Medical Director. Customers were asked to complete the attached form and fax it to (302) 631-8467. For questions regarding this recall call 800-441-9250.
Quantity in commerce: 4175
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Canada, Belgium, Switzerland, Germany, Spain, France, Great Britain, Italy, Saudi Arabia, Australia, and Japan.
Product codes and lots: CSA 13114BA, exp. 2014-04-24; CSA 13157BA, exp. 2014-06-06; CSA 13246BB, exp. 2014-09-03; CSA 13317BA, exp. 2014-11-13; CSA 14008BB, exp. 2015-01-08; CSA 14050BB, exp. 2015-02-19; CSAE 13157BC, exp. 2014-06-06; CSAE 13249BD, exp. 2014-09-06.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1647-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1647-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-28	2014-05-21

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)