Siemens Dimension Vista HDLC Reagent Cartridges Recalled for Erroneous Results
Siemens Healthcare Diagnostics is recalling Dimension Vista HDLC reagent cartridges due to discolored reagents that may cause erroneous test results.
What this means for you
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, and the hazard involves erroneous diagnostic results without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling Dimension Vista HDLC colorimetric method lipoprotein reagent cartridges. The recall is due to the potential for erroneous results caused by discolored reagent observed in some wells 5 and 6 of the cartridges.
The affected product is identified by Lot number 20062BA. A total of 4,174 devices are involved in the recall, with 2,836 distributed domestically and 1,338 distributed internationally. The product was distributed worldwide, including in the United States and various countries in Europe and Canada.
The Dimension Vista HDLC product is used as an aid in the diagnosis of lipid disorders, liver and renal diseases, and in the assessment of risk for atherosclerosis and cardiovascular disease. Users should check their inventory for the specific lot number and stop using the affected cartridges.
The recalled product
- Product
- Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), various liver and renal diseases, and in the assessment of risk for atherosclerosis and cardiovascular disease.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
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 (3)
- Product: DV HDLC
- Lot #: 20062BA
- UDI Number: 0084276802043820062BA21030210464340840
Distribution
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