Siemens Dimension Vista Homocysteine Reagent Cartridge Recalled for Erratic Results
Siemens Healthcare Diagnostics is recalling Dimension Vista Homocysteine Flex Reagent Cartridges due to erratic quality control and patient sample recovery.
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) where specific injuries or illnesses have not yet been reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 302 units of the Dimension Vista Homocysteine Flex Reagent Cartridge, lot 13064MA. The product is an in vitro diagnostic test used to measure total homocysteine in human serum and plasma on the Dimension Vista System.
The recall was initiated because the affected lot shows erratic recovery of quality control and patient samples. This issue may affect the accuracy of test results used in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
The recalled product was distributed worldwide, including in the United States (OH, MD, CO, NJ, IA, NC, VA, WI, and DC) and in Austria, Denmark, France, Italy, the Netherlands, and Norway. The expiration date for the affected lot is March 5, 2014. Users should stop using the affected lot and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- Siemens Dimension Vista Homocysteine Flex Reagent Cartridge The HCYS method is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and ETDA plasma on the Dimension Vista System. Measurements of homocysteine aid…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 302
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 (2)
- lot 13064MA
- expiration 2014-03-05
Distribution
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