CLASS II Device recall · Reported 14 Oct 2020 · FDA Enforcement Report
Dimension Loci High Sensitivity Troponin I recalled
Siemens Healthcare Diagnostics is recalling Dimension Loci High Sensitivity Troponin I (Tnih) Flex reagent cartridge-Ivd-In vitro, distributed nationwide in the US. The recall was initiated on 19 Aug 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-0052-2021
- FDA event ID
- 86374
- Recalling firm
- Siemens Healthcare Diagnostics, Newark, DE
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Aug 2020
- FDA classified
- 2 Oct 2020
- Reported
- 14 Oct 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 19 Aug 2020 | Recall initiated by company | |
| 2 Oct 2020 | Classified by FDA | +44 days |
| 14 Oct 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Positive bias across the Analytical Measurement Range of the TNIH assay compared to an unaffected control lot. The average bias observed for patient samples using lots EB0255 and EA0178 of the Dimension EXL Troponin compared with a control lot was +25%. A maximum bias of +34% in patient samples around the 99th percentile observed
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Dimension LOCI 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: RF627, SMN# 10471068
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
Positive bias across the Analytical Measurement Range of the TNIH assay compared to an unaffected control lot. The average bias observed for patient samples using lots EB0255 and EA0178 of the Dimension EXL Troponin compared with a control lot was +25%. A maximum bias of +34% in patient samples around the 99th percentile observed
Which lots are affected?
Lot # EB0255 UDI: 00842768037726EB025520091110471068840
Where was it sold?
US Nationwide distribution.
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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