Dimension Vista HDLC Reagent Cartridge Recalled for Inaccurate Lab Results
Siemens is recalling 1,592 units of Dimension Vista HDLC reagent cartridges due to potential for erroneous test results. Affected cartridges may produce falsely high or low HDL cholesterol measurements.
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: FDA Class II device with potential for test results deviating -90% to 133% from correct values, affecting patient diagnosis and clinical decision-making. No illnesses or hospitalizations are reported in the source material, and the hazard is characterized as potential rather than confirmed. This meets the rubric criterion for risk-of-harm products without reported injury, scoring 3 (High).
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridges used in clinical laboratories to measure HDL cholesterol levels in patient blood samples.
The cartridges may produce inaccurate test results. When a sample is processed without an "Abnormal Reaction" [E145] flag—a warning indicator that should have been generated—the reported HDL cholesterol value may be falsely high or low, with potential variance of -90% to 133% from the correct value.
Approximately 1,592 units of the affected cartridge (Lot 21250BA, expiration date September 7, 2022) were distributed nationwide and to Canada. The cartridges are identified by Siemens Material Number 10464340 and Catalog Number K3048A.
The recalled product
- Product
- Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Siemens Material Number (SMN): 10464340 Catalog Number: K3048A
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 1,592
Distribution
Distributed nationwide across the United States.
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