CSL Behring Recalls Dimension Vista Homocysteine Reagent Cartridges
CSL Behring is recalling 898 units of Dimension Vista Homocysteine Flex Reagent Cartridges because opened lots show reduced stability and do not meet the 7-day claim.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
CSL Behring GmbH is recalling 898 units of Dimension Vista Homocysteine Flex Reagent Cartridges (HCYS), Device Listing No. D017878. The affected lots are 15243MA and 15243MB, both manufactured on August 31, 2015, and expiring on May 31, 2016. These in vitro diagnostic tests are used for the quantitative measurement of total homocysteine in human serum, heparinized plasma, and EDTA plasma on the Dimension Vista System.
The recall was initiated because the reagent lots show reduced stability once opened, which does not meet the Instructions For Use claim of seven days. A maximum bias of -37% was observed in the affected units. The products were distributed to laboratories and facilities in 35 states and the District of Columbia, including Alabama, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Wisconsin, and West Virginia.
Users of these reagent cartridges should stop using the affected lots immediately and contact CSL Behring GmbH for instructions on return or replacement. This recall is classified as FDA Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Dimension Vista¿ Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878 is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and EDTA plasma on the Dimension Vista System.
- Manufacturer
- CSL Behring GmbH
- Affected units
- 898
Distribution
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