Siemens Dimension Vista CTNI Sample Diluent Recalled for Defective Cap Septum
Siemens Healthcare Diagnostics is recalling 1,446 units of Dimension Vista CTNI Sample Diluent because a defective cap septum may cause erroneously elevated test results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is limited to erroneous test results rather than direct physical injury or hospitalization, fitting the criteria for a moderate severity score.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 1,446 units of Dimension Vista CTNI Sample Diluent (KD692, SMN# 10445205). The recall is due to a potential defect where the vial cap septum may have an incomplete slit. This defect can reduce the volume of diluent pipetted from the vial during onboard autodilution, which has the potential to cause erroneously elevated test results.
The affected product is identified by lot # 17171BD and UDI # 008427680158927BDA3418060110445205. The products were distributed to 48 US states, the District of Columbia, Guam, Saipan, and the Virgin Islands. Additionally, the products were distributed to 28 countries, including Australia, Canada, Germany, Japan, and the United Arab Emirates.
Healthcare facilities and consumers should stop using the affected product and contact Siemens Healthcare Diagnostics for instructions on return or replacement. The FDA has classified this recall as Class II, indicating that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Dimension Vista¿ CTNI Sample Diluent, KD692, SMN# 10445205
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 1,446
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 (2)
- lot # 17171BD
- UDI # (UDI) 008427680158927BDA3418060110445205
Distribution
Part of a larger recall action
This product is one of 3 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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