Siemens Healthcare recalls ADVIA Centaur CKMB Calibrator 2-packs for potential calibration bias with internal standards. Affected units have specific lot numbers and were sold in Japan. No action required as the hazard is minor and does not pose serious injury risk.
A potential bias was identified with certain kits compared to the internal standards.
Siemens Healthcare is recalling ADVIA Centaur CKMB Calibrator 2-packs sold in Japan due to a potential calibration bias issue. This means the kits might not align correctly with internal standards, but it does not cause serious injury or health risks. The recall is for quality assurance and does not require immediate action.
The calibrator kits may show a bias when compared to internal standards, meaning calibration results could be slightly off. This does not cause physical harm but might lead to inaccurate test results in laboratory settings.
Users of ADVIA Centaur CKMB Calibrator 2-packs in Japan who perform in vitro diagnostic calibrations. Laboratory staff handling these kits are most at risk if they rely on inaccurate calibration results.
Check for the lot numbers 58311A67 or 97468A67 on the packaging, which were sold in Japan with expiration dates of December 11, 2018. The product is labeled for in vitro diagnostic use in calibrating ADVIA Centaur systems.
Verify the lot number on the packaging to confirm if it is 58311A67 or 97468A67.
No action is required as the hazard is minor and does not pose serious injury risk.
A potential bias was identified when comparing the kits to internal standards, which could lead to slightly inaccurate calibration results.
Look for lot numbers 58311A67 or 97468A67 on the packaging, which were sold in Japan with an expiration date of December 11, 2018.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0114-2019 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0114-2019 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.
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.
