Siemens Healthcare recalls Dimension LOCI High Sensitivity Troponin I (TNI: Flex) reagent cartridges with potential positive bias in cardiac troponin I measurements, risking inaccurate test results.
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
Take action
Contact the company
📍Recalling firmSiemens Healthcare Diagnostics, Inc.500 Gbc Dr · Newark, DE 19702-2466
“Siemens Dimension LOCI TNIH Flex Reagent Cartridge Recall: Positive Bias Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64451-siemens-dimension-loci-tnih-flex-reagent-cartridge-recall-positive-bias. Based on FDA recall #Z-0052-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0052-2021%22&limit=1).
The FDA announced on Aug. 19, 2020, that Siemens Healthcare Diagnostics, Inc. is recalling Dimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridges due to a positive bias in test results. The agency said the defect could lead to falsely elevated troponin measurements.
How to tell if you have it
Brand: Siemens Healthcare
Product: Dimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridge
Catalog Number: RF627, SMN# 10471068
Lot # EB0255
Lot # EA0178
UDI: 00842768037726EB025520091110471068840
The hazard
According to the FDA, the recalled lots exhibit a positive bias across the Analytical Measurement Range compared to an unaffected control lot. The agency reported an average bias of +25% in patient samples for lots EB0255 and EA0178, with a maximum bias of +34% observed around the 99th percentile.
Context
GovInfoNow's records show Siemens Healthcare Diagnostics, Inc. has had 150 other recalls on record since June 7, 2017. Other recent recalls of similar products include Siemens Atellica CH RCRP Test May Give False High Results (Aug. 17, 2026), Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall (July 13, 2026), and Siemens Atellica CH Urine Albumin Recall (July 6, 2026). Other recent recalls of similar products include HardyDisk AST Cefiderocol 30μg FDC30 (June 8, 2026), Menopause Test Cassette Recall (Nov. 22, 2025), and Changchun Wancheng Bio-Electron UTI Test Strips Recall (Nov. 22, 2025).
How to tell if you have this one
Check for lot numbers EB0255 or EA0178 on the cartridge packaging. The product was sold with catalog number RF627 and UDI code 00842768037726EB025520091110471068840.
Brand
Siemens Healthcare
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Cartridge Lot Number
Look for lot numbers EB0255 or EA0178 on the cartridge packaging to determine if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 3 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0052-2021 (August 19, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0052-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.