Siemens Healthcare recalls Dimension CTNI test kits that may give false positive results for heart attacks in low-risk patients, leading to unnecessary interventions. Affected kits have specific lot numbers and expiration dates.
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 recalls Dimension CTNI tests that may incorrectly indicate a heart attack in patients with low cardiac troponin-I levels. This could lead to unnecessary medical procedures if the test is used without proper context.
The test may produce a false positive result when using lithium heparin plasma samples from patients with cardiac troponin-I levels below 0.07 ng/mL. This could lead to inappropriate heart attack treatments for patients who don't actually have a heart attack.
Patients using the Dimension CTNI test for cardiac troponin-I levels may be at risk of unnecessary heart attack interventions if the test shows a false positive. Healthcare providers ordering the test are most affected.
Check for the Siemens Material Number (SMN) 10444905/RF421C or UDI-DI 00842768013836. The lot number GA2323 expires November 19, 2022, and BA3088 expires March 29, 2023.
Review the Siemens Material Number (SMN) 10444905/RF421C or UDI-DI 00842768013836 on the test kit.
The test may give a false positive result for heart attack in patients with low cardiac troponin-I levels, potentially leading to unnecessary medical procedures.
Dimension CTNI tests with Siemens Material Number 10444905/RF421C and UDI-DI 00842768013836, including lot numbers GA2323 (exp. Nov 19, 2022) and BA3088 (exp. March 29, 2023).
No specific stop-use instruction is provided; the recall focuses on identifying affected tests for potential review.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1341-2022 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1341-2022 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
