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
Siemens Healthcare is recalling Dimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridges that may give falsely high results for cardiac troponin I tests. This could lead to incorrect diagnoses of heart conditions if used in medical testing.
The reagent cartridges may produce results that are 25-34% higher than expected for cardiac troponin I tests. This positive bias could lead to false positive diagnoses of heart conditions when used with the Dimension EXL system.
Healthcare providers using the Dimension EXL Troponin reagent cartridges with specific lot numbers for cardiac tests. Patients receiving inaccurate heart test results due to faulty cartridges.
Check for lot numbers EB0255 or EA0178 on the cartridge packaging. The product was sold with catalog number RF627 and UDI code 00842768037726EB025520091110471068840.
Look for lot numbers EB0255 or EA0178 on the cartridge packaging to determine if it's affected.
The reagent may produce results that are 25-34% higher than expected for cardiac troponin I tests, potentially leading to false positive diagnoses.
The recall record does not specify a remedy or action for affected cartridges.
Check for lot numbers EB0255 or EA0178 on the cartridge packaging. The product was sold with catalog number RF627 and UDI code 00842768037726EB025520091110471068840.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0052-2021 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0052-2021 from Siemens Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
