FDAFDA · Food and drugs·Recall number Z-0127-2015
Dimension Vista¿ HbA1c
Published November 5, 2014 · Recall initiated: August 14, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Distributor
- Worldwide Distribution: US (nationwide) and country of: Canada.
- Lot
- catalog #K3105A, material #10470481, All in-date lots
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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