Siemens Healthcare recalls Dimension LTNI cardiac test kits that may show falsely high heart attack levels in some patients, leading to unnecessary treatments. Affected kits have specific serial numbers and were sold from 2022.
Positive bias with Lithium Heparin plasma samples from individuals that are expected to be below the 99th percentile of 0.07 ng/mL [0.07 ¿g/L], may lead to inappropriate intervention for myocardial infarction
Siemens Healthcare is recalling Dimension LTNI test kits that may give false high results for heart attacks in some patients. This could lead to unnecessary treatments if the test shows a heart attack when there isn't one.
The test may show higher levels of cardiac troponin-I than actually present in some patients using lithium heparin plasma samples. This could lead to unnecessary heart attack treatments if the test indicates a heart attack when there isn't one.
People who use the Dimension LTNI test kits for heart attack diagnosis, especially those with low cardiac troponin-I levels. Those with very low levels might get a false positive result.
Check for the Siemens Material Number (SMN) 10444896/RF521 or UDI-DI 00842768013904EA231420221110 on the test kit. The lot number is EA2314 with an expiration date of November 10, 2022.
Look for the Siemens Material Number (SMN) 10444896/RF521 or UDI-DI 00842768013904EA231420221110 on the test kit.
The test may show falsely high results for cardiac troponin-I in some patients using lithium heparin plasma samples, which could lead to unnecessary heart attack treatments.
Check the test kit for the Siemens Material Number (SMN) 10444896/RF521 or UDI-DI 00842768013904EA231420221110. If it matches, contact Siemens Healthcare for instructions.
No, the test is safe when used properly. The recall is due to a potential for false high results in specific samples, not a safety hazard.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1340-2022 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1340-2022 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.
