Dimension Vista High Sensitivity Troponin I recall
Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac…
Why was Dimension Vista High Sensitivity Troponin I recalled?
Dimension Vista High Sensitivity Troponin I (TNIH) may exhibit a negative bias with patient samples
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?
Lot # 20008BB UDI: 0084276803771920135BB21031010471067840; Lot #20035BC UDI:0084276803771920035BC20113010471067840; Lot #20135BB UDI: 0084276803771920008BB20110310471067840
- Product
- Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- US: 1239 units OUS: 3387
- Distribution
- Nationwide
- Recall date
- September 9, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)