FDAFDA · Food and drugs·Recall number Z-2927-2020
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
Published September 9, 2020 · Recall initiated: July 24, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Dimension Vista High Sensitivity Troponin I (TNIH) may exhibit a negative bias with patient samples
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Distributor
- Nationwide
- Lot
- Lot # 20008BB UDI: 0084276803771920135BB21031010471067840; Lot #20035BC UDI:0084276803771920035BC20113010471067840; Lot #20135BB UDI: 0084276803771920008BB20110310471067840
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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