Siemens Dimension Vista HbA1c Reagent Cartridges Recalled for Sample Bias
Siemens is recalling Dimension Vista HbA1c reagent cartridges because whole blood samples from Small Sample Containers may produce inaccurate HbA1c values.
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: The recall involves a medical device with a significant risk of inaccurate diagnostic results (HbA1c bias) which could impact patient care, but the source text does not report any injuries, illnesses, or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling Dimension Vista HbA1c reagent cartridges (catalog #K3105A, material #10470481) due to an urgent medical device correction. The recall affects all in-date lots of the product.
The recall was issued because decreased recovery of patient samples was identified when whole blood samples are run from Small Sample Containers (SSC). Siemens has confirmed that this specific testing condition may result in HbA1c values exhibiting a percent bias ranging from -8.2% to an unspecified upper limit. The source text does not specify the maximum bias value or report any patient injuries or illnesses.
The affected products were distributed nationwide in the United States and in Canada. Healthcare facilities and laboratories using these cartridges with whole blood samples from Small Sample Containers should stop using the affected lots and contact Siemens for further instructions or replacement.
The recalled product
- Product
- Dimension Vista¿ HbA1c
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 20,043
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- catalog #K3105A
- material #10470481
- All in-date lots
Distribution
Distributed nationwide across the United States.
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