Dimension Vista¿ CSA and CSAE The Cyclosporine method recall
Dimension Vista¿ CSA and CSAE The Cyclosporine method is an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human…
Why was Dimension Vista¿ CSA and CSAE The Cyclosporine method 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- 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…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 4175
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Canada, Belgium, Switzerland, Germany, Spain, France, Great Britain, Italy, Saudi Arabia, Australia, and Japan.
- Recall date
- May 28, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)