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

FDA device recall Z-1647-2014 · posted 2014-05-21 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

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

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

MKW

Quantity affected

4175

Distribution

Worldwide Distribution - USA (nationwide) and Internationally to Canada, Belgium, Switzerland, Germany, Spain, France, Great Britain, Italy, Saudi Arabia, Australia, and Japan.

Date initiated

2014-03-19

Date posted

2014-05-21

Date terminated

2015-08-10

Location

Newark, DE

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