FDA-Device2022-10-26Class II
Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Siemens Material Number (SMN): 10464340 Catalog Number: K3048A
Siemens Healthcare Diagnostics, Inc.
Hazard
Dimension Vista¿ High Density Lipoprotein Cholesterol (HDLC) Potential for Erroneous Result. If an HDLC QC or patient result is obtained without an Abnormal Reaction [E145]: flag, a falsely depressed or elevated result ranging from -90% to 133% may be observed.
Sold states
Nationwide Foreign: Canada
Affected count
1592 units
Manufactured in
500 Gbc Dr, N/A, Newark, DE, United States
Products
Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Siemens Material Number (SMN): 10464340 Catalog Number: K3048A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0089-2023Don't want to check this manually?
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