Siemens Recalls Dimension Vista Cyclosporine Flex Reagent Cartridges
Siemens Healthcare Diagnostics is recalling 1,586 Dimension Vista Cyclosporine Flex reagent cartridges due to complaints about variability in quality control and patient results.
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 potential diagnostic errors in a high-risk patient population (transplant patients) without reported injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 1,586 units of the Dimension Vista Cyclosporine Flex reagent cartridge. This in vitro diagnostic test is used to measure cyclosporine A levels in human whole blood to aid in the management of heart, liver, and kidney transplant patients.
The recall was initiated after complaints were received regarding variability in the recovery of quality control and patient results for certain lots of the cartridges. The affected lots are 12300BB (exp. 10-26-2013), 12318BB (exp. 11-13-2013), and 13011BB (exp. 1-11-2014). The products were distributed nationwide in the United States and in Canada.
This is a Class II recall, which means the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. Healthcare facilities should stop using the affected cartridges and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- Dimension Vista Cyclosporine Flex reagent cartridge an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista System. Measurements are used as an aid in the management of heart, liver, and kidney…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 1,586
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 (6)
- lots 12300BB
- exp. 10-26-2013
- 12318BB
- exp. 11-13-2013
- and 13011BB
- exp. 1-11-2014.
Distribution
Distributed nationwide across the United States.
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