Siemens Healthcare recalls ADVIA Centaur CKMB Calibrator kits with potential calibration bias. Affected lots may cause inaccurate test results. Contact for details.
A potential bias was identified with certain kits compared to the internal standards.
Siemens Healthcare is recalling ADVIA Centaur CKMB Calibrator kits that may cause inaccurate test results due to calibration bias. This could lead to incorrect medical diagnoses if used without correction.
The calibrator kits may show calibration bias compared to internal standards, potentially leading to inaccurate test results. This could affect the accuracy of medical diagnoses if not corrected.
Healthcare labs using the ADVIA Centaur CKMB Calibrator kits with specific lot numbers may be affected. Patients relying on accurate diagnostic results from these kits could be impacted.
Check the lot number on the kit label. Affected lots include 57834A64, 57835A64, 72519A64, and 98115A64, all with an expiration date of December 11, 2018.
Look for the lot number on the calibrator kit label to determine if it is affected.
Siemens Healthcare is recalling ADVIA Centaur CKMB Calibrator kits with potential calibration bias that could lead to inaccurate test results.
Affected lots are 57834A64, 57835A64, 72519A64, and 98115A64, all with an expiration date of December 11, 2018.
No specific stop-use instruction is provided; the recall focuses on potential calibration bias that may require correction.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0113-2019 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0113-2019 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.