FDA-Device2014-11-05Class II
Dimension Vista¿ HbA1c
Siemens Healthcare Diagnostics, Inc.
Hazard
In March, Siemens Healthcare Diagnostics issued an Urgent Medical Device Correction for decreased recovery of patient samples with the Dimension Vista® CSA & CSAE Flex® reagent cartridges when whole blood samples are run from Small Sample Containers (SSC). Siemens has confirmed that when whole blood samples are run from SSC, HbA1c values may exhibit a percent bias ranging from - 8.2% t
Sold states
Worldwide Distribution: US (nationwide) and country of: Canada.
Affected count
20043
Manufactured in
500 Gbc Dr Ms 514, PO BOX 6101, Newark, DE, United States
Products
Dimension Vista¿ HbA1c
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0127-2015Don't want to check this manually?
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