Dimension LOCI High Sensitivity Troponin I (TNIH) Flex… recallZ-0052-2021 · Siemens Healthcare Diagnostics, Inc. · initiated Aug 19, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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
FDA root cause category: Under Investigation by firm
What the company is doing
Siemens issued Urgent Medical Device Correction (UMDC # VC-20-03.B.US) and Urgent Field Safety Notice (UFSN # VC-20-03.B.OUS) issued on August 19, 2020 via FedX to US Dimension customers who received the Dimension TNIH reagent lot to notify them of the issue, the risk to health, and the following actions to be taken by the customer: Review the letter with their Medical Director"If they are using TNIH lot EB0255 DO NOT switch to another TNIH lot during serial measurements for a single patient sample. Discontinue use and discard the TNIH reagent lot EB0255 upon receipt of replacement product. Request your no-charge replacement for lot EB0255. Complete and return the Field Correction Effectiveness Check Form attached to the letter within 30 days. Questions, contact your Siemens Remote Services Center or your local Siemens Technical Support representative.
Recall details
- Recall number
- Z-0052-2021
- Status
- Terminated
- Initiated by the company
- Aug 19, 2020
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 533 US and 1822 OUS
- Product code
- MMI
- FDA submissions
- K190675
- Distribution
- US Nationwide distribution.
Product description
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
Code information (models, lots, serial numbers)
Lot # EB0255 UDI: 00842768037726EB025520091110471068840
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Dimension EXL LOCI Troponin I High Sensitive 10471068Siemens Healthcare Diagnostics Inc. · IMMUNOASSAY METHOD, TROPONIN SUBUNIT1 recall76 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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