Dimension Vista¿ HbA1c recall
Dimension Vista¿ HbA1c
Why was Dimension Vista¿ HbA1c recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
catalog #K3105A, material #10470481, All in-date lots
- Product
- Dimension Vista¿ HbA1c
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 20043
- Distribution
- Worldwide Distribution: US (nationwide) and country of: Canada.
- Recall date
- November 5, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)