Reported May 28, 2014 · Terminated
Dimension Vista¿ CSA and CSAE The Cyclosporine method is an in vitro diagnostic test for the quantitative measurement…
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 500 Gbc Dr Ms 514 · Newark, DE · 19702-2466
Is this the product you have?
- 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.
- Lot codes and dates
8 of 8 products
Products covered by this recall # Product as published 1 CSA 13114BA, exp. 2014-04-24 2 CSA 13157BA, exp. 2014-06-06 3 CSA 13246BB, exp. 2014-09-03 4 CSA 13317BA, exp. 2014-11-13 5 CSA 14008BB, exp. 2015-01-08 6 CSA 14050BB, exp. 2015-02-19 7 CSAE 13157BC, exp. 2014-06-06 8 CSAE 13249BD, exp. 2014-09-06. - Amount recalled
- 4175
Where it was sold
- Nationwide
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
This product could cause temporary or reversible health problems — stop using it.
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