Siemens Recalls Dimension Vista Cyclosporine Test Kits Due to Under-Recovery
Siemens Healthcare Diagnostics is recalling Dimension Vista CSA and CSAE test kits because they may under-recover cyclosporine levels when using Small Sample Containers.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (inaccurate diagnostic results for transplant patients) where specific injury or illness has not yet been reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 4,175 units of Dimension Vista CSA and CSAE in vitro diagnostic test kits. These kits are used to measure cyclosporine A levels in human whole blood to help manage heart, liver, and kidney transplant patients.
The recall was initiated after a complaint reported that the test kits under-recovered cyclosporine by 18 to 44% when patient samples were run from the Small Sample Container. This under-recovery could lead to inaccurate test results.
The affected products were distributed nationwide in the United States and internationally to Canada, Belgium, Switzerland, Germany, Spain, France, Great Britain, Italy, Saudi Arabia, Australia, and Japan. Specific lot numbers and expiration dates are listed in the agency's recall record. Users should stop using the affected lots and contact Siemens Healthcare Diagnostics for instructions on how to proceed.
The recalled product
- 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…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 4,175
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- 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
- CSAE 13249BD
- exp. 2014-09-06.
Distribution
Distributed nationwide across the United States.
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