CLASS II Device recall · Reported 9 Sep 2020 · FDA Enforcement Report
Dimension Vista High Sensitivity Troponin I recalled
Siemens Healthcare Diagnostics is recalling Dimension Vista High Sensitivity Troponin I (Tnih) Flex reagent cartridge-Ivd-In vitro, distributed nationwide in the US. The recall was initiated on 24 Jul 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2927-2020
- FDA event ID
- 86151
- Recalling firm
- Siemens Healthcare Diagnostics, Newark, DE
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Jul 2020
- FDA classified
- 2 Sep 2020
- Reported
- 9 Sep 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 24 Jul 2020 | Recall initiated by company | |
| 2 Sep 2020 | Classified by FDA | +40 days |
| 9 Sep 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Dimension Vista High Sensitivity Troponin I (TNIH) may exhibit a negative bias with patient samples
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Dimension Vista High Sensitivity Troponin I (TNIH) may exhibit a negative bias with patient samples
Which lots are affected?
Lot # 20008BB UDI: 0084276803771920135BB21031010471067840; Lot #20035BC UDI:0084276803771920035BC20113010471067840; Lot #20135BB UDI: 0084276803771920008BB20110310471067840
Where was it sold?
Nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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