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
Reported: September 9, 2020 Initiated: July 24, 2020 #Z-2927-2020
Product Description
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
Reason for Recall
Dimension Vista High Sensitivity Troponin I (TNIH) may exhibit a negative bias with patient samples
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- US: 1239 units OUS: 3387
- Distribution
- Nationwide
- Location
- Newark, DE
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: US: 1239 units OUS: 3387.
Why was this product recalled? ▼
Dimension Vista High Sensitivity Troponin I (TNIH) may exhibit a negative bias with patient samples
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 9, 2020. Severity: Moderate. Recall number: Z-2927-2020.
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