Siemens Healthcare recalls ADVIA Centaur CKMB Master Curve Material (Cat No. 07867768) due to potential bias in diagnostic results compared to internal standards. Affected lots from 2019-02-10 to 2020-06-11 may cause inaccurate test results.
A potential bias was identified with certain kits compared to the internal standards.
Siemens Healthcare is recalling ADVIA Centaur CKMB Master Curve Material because it may cause inaccurate diagnostic results when compared to internal standards. This affects laboratory tests that use the material for evaluating CKMB levels in blood samples.
The material may produce results that differ from the internal standards used in the testing system, potentially leading to inaccurate diagnostic conclusions. This bias could affect the accuracy of CKMB level measurements in blood samples.
Laboratories using the ADVIA Centaur CKMB Master Curve Material for in vitro diagnostic testing are affected. Users most at risk are those who rely on the material for accurate CKMB level measurements in blood tests.
Check the lot number on the material packaging. Affected lots include 35061 (expiring February 10, 2019) and 39753 (expiring June 11, 2020).
Identify the lot number on the packaging to determine if it is affected (35061 or 39753).
The ADVIA Centaur CKMB Master Curve Material (Cat No. 07867768) used for in vitro diagnostic testing of CKMB levels in blood samples.
A potential bias was identified with certain kits compared to the internal standards, which could lead to inaccurate diagnostic results.
Check the lot number on the packaging; affected lots are 35061 (expiring February 10, 2019) and 39753 (expiring June 11, 2020).
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0115-2019 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0115-2019 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.
