Siemens Healthcare recalls Stratus CS Acute Care cTNI TestPak due to potential for increased false positive results in cardiac troponin I tests. This may lead to incorrect heart attack diagnoses.
Potential for increased rate of false positive results and/or increased rate of random non-repeatable false positive results.
Siemens Healthcare is recalling its Stratus CS Acute Care cTNI TestPak for possible false positive results in cardiac tests. This could lead to incorrect heart attack diagnoses if the test is used improperly.
The test may produce more false positive results, meaning it could indicate a heart attack when there isn't one. This might lead to unnecessary treatments or anxiety for patients.
Healthcare providers using the Stratus CS Acute Care cTNI TestPak for cardiac troponin I testing are affected. Patients receiving this test may be at risk of incorrect heart attack diagnoses.
Check for the product name 'Stratus CS Acute Care cTNI TestPak' with lot number 238330002. The product was sold with expiration dates of May 25, 2019, and November 2, 2019.
Identify the lot number and expiration dates to confirm if your test kit is affected.
The recall does not state that the test is dangerous when used correctly; it only mentions potential for false positives.
The recall record does not specify a remedy, so no action is required beyond checking the product details.
The test may produce false positive results, which could lead to incorrect heart attack diagnoses and unnecessary treatments.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2135-2019 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2135-2019 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.
