Siemens Healthcare recalls ADVIA Centaur Cortisol 50T and 250T urine test kits due to potential negative bias in urine patient samples causing QC results to be out of range. Affected kits have specific model numbers and lot ranges.
There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low.
Siemens Healthcare is recalling ADVIA Centaur Cortisol 50T and 250T urine test kits because they can give inaccurate results for urine cortisol tests. This could lead to incorrect medical diagnoses if used without proper calibration.
The test kits can produce negative bias in urine patient samples, meaning results may be lower than actual cortisol levels. This can cause urine cortisol Quality Control (QC) results to occasionally fall outside the expected range, potentially leading to incorrect medical interpretations.
Healthcare labs using these specific urine cortisol test kits are affected. Patients receiving results from these kits may have inaccurate cortisol measurements.
Check for model numbers: ADVIA Centaur Cortisol 50T (Material 10994924) or 250T (Material 10994926). Kits with specific UDI-DI and lot numbers listed in the recall notice are affected.
Compare your kit's lot numbers with the affected ranges listed in the recall notice.
No, the recall does not require immediate discontinuation. The kits can still be used but may need to be checked against the affected lot numbers.
The kits may produce inaccurate results for urine cortisol tests, potentially leading to incorrect medical diagnoses if not properly calibrated.
Check the kit's UDI-DI and lot numbers against the specific ranges listed in the recall notice.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1505-2023 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1505-2023 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.
