Siemens Dimension Vista Troponin I Reagent Cartridge Recalled for Negative Bias
Siemens Healthcare Diagnostics is recalling Dimension Vista High Sensitivity Troponin I reagent cartridges because they may exhibit a negative bias with patient samples.
What this means for you
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 is classified as FDA Class II, and the hazard involves a potential negative bias in diagnostic results which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridges. The affected product is an in vitro diagnostic (IVD) used for the quantitative measurement of cardiac troponin I in human plasma. The recall involves Catalog Number K6427 and SMN# 104471067.
The recall was initiated because the reagent cartridges may exhibit a negative bias with patient samples. This potential bias could affect the accuracy of the quantitative measurements. The agency has classified this recall as Class II.
The recall covers 1,239 units in the United States and 3,387 units outside the United States. Distribution was nationwide. Affected lots include Lot # 20008BB, Lot #20035BC, and Lot #20135BB. Users should check their inventory for these specific lot numbers and contact the manufacturer for further instructions.
The recalled product
- Product
- Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac troponin I in human plasma Catalog Number K6427, SMN# 104471067
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
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)
- Lot # 20008BB UDI: 0084276803771920135BB21031010471067840
- Lot #20035BC UDI:0084276803771920035BC20113010471067840
- Lot #20135BB UDI: 0084276803771920008BB20110310471067840
Distribution
Distributed nationwide across the United States.
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