—#126326

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.

FDA product code: MKW — Cyclosporine
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K062236
Affected lot / code info: 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.

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr PO BOX 6101, Ms 514, Newark, Delaware 19702-2466

Distribution

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

Timeline

Recall initiated: 2014-03-19
Posted by FDA: 2014-05-21
Terminated: 2015-08-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #126326. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.