Recall Z-2927-2020— Siemens Healthcare Diagnostics, Inc.
Class II · Terminated
Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2020-07-24, terminated 2023-06-07. It names one FDA 510(k) clearance: K182225. 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. Reason: Dimension Vista High Sensitivity Troponin I (TNIH) may exhibit a negative bias with patient samples.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-07-24
- Terminated
- 2023-06-07
- Firm location
- Newark, DE, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.