Siemens Healthcare recalls Dimension Vista High Sensitivity Troponin I reagent cartridges that may show false negative results in cardiac troponin I tests. Affected lots and model numbers are listed in the recall notice.
Dimension Vista High Sensitivity Troponin I (TNIH) may exhibit a negative bias with patient samples
Siemens Healthcare is recalling Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridges because they may show false negative results with patient samples. This could lead to incorrect cardiac test results if the cartridge is used without knowing it's faulty.
The reagent cartridges may produce false negative results when testing for cardiac troponin I in patient samples. This means the test might incorrectly show no cardiac damage when damage is actually present. False negatives could lead to missed diagnoses of heart conditions.
Healthcare facilities using the Dimension Vista High Sensitivity Troponin I reagent cartridges are likely affected. Patients receiving cardiac tests using these cartridges could be at risk of incorrect results.
Check for the catalog number K6427, SMN# 104471067, or lot numbers 20008BB, 20035BC, or 20135BB. The unique device identifier (UDI) codes are also listed in the recall notice.
Look for the lot number on the cartridge label: 20008BB, 20035BC, or 20135BB.
Check the unique device identifier (UDI) on the cartridge: 0084276803771920135BB210310471067840 or similar codes listed in the recall.
The Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridges may show false negative results with patient samples, which could lead to incorrect cardiac test results.
The recall notice does not specify a remedy, so check the lot number or UDI code to confirm if your cartridge is affected. Contact Siemens Healthcare for further instructions.
Check for the lot numbers 20008BB, 20035BC, or 20135BB, or the unique device identifier (UDI) codes listed in the recall notice.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2927-2020 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2927-2020 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.
