Siemens Healthcare recalls ADVIA hsCR:RP calibrators due to accuracy drift causing high bias in patient samples. Affected units may need recalibration or replacement.
Atellica and ADVIA hsCRP calibrator accuracy has drifted away from the reference materials (ERM-DA470/IFCC), which is causing a high bias on QC and patient sample recovery.
Siemens Healthcare is recalling ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP) calibrators because they've lost accuracy compared to reference materials. This could lead to incorrect patient test results if used without correction.
The calibrators have drifted from reference standards, causing test results to be too high. This could lead to incorrect patient diagnoses if not corrected.
Lab technicians and healthcare facilities using Siemens ADVIA Chemistry systems for hsCRP testing. Those with the specific calibrator model and lot numbers are most at risk.
Check for the Siemens Material Number (SMN) 10335897, lot number 453610, or expiration date January 2020 on the calibrator packaging.
Look for the Siemens Material Number (SMN) 10335897, lot number 453610, or expiration date January 2020 on the calibrator packaging.
The calibrators have drifted from reference standards, causing test results to be too high and potentially leading to incorrect patient diagnoses.
Check the calibrator packaging for the Siemens Material Number (SMN) 10335897, lot number 453610, or expiration date January 2020. If it matches, contact Siemens Healthcare for guidance.
The recall record does not specify a remedy or fix for this issue.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1260-2020 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1260-2020 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.
