Siemens ADVIA Centaur Calibrator 30 Recall: Negative Bias in Estradiol Testing
Siemens Healthcare recalls ADVIA Centaur Calibrator 30 kits with specific lot numbers due to potential negative bias in estradiol testing results. Affected kits may produce inaccurate eE2 measurements.
Lower-risk recall
Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur Enhanced Estradiol (eE2) on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT systems when calibrating with Calibrator 30 kit lots ending in 21 (C3021) as compared to Calibrator 30 kit lots ending in 20 (C3020).
Contact the company
What happened, in plain English
Siemens Healthcare is recalling ADVIA Centaur Calibrator 30 kits that could cause inaccurate estradiol (eE2) test results. This means test results might be too low, potentially leading to incorrect health decisions. Read more at govinfonow.com/recall/73916-siemens-advia-centaur-calibrator-30-recall-negative-bias-in-estradiol.
Source Summary by GovInfoNow · govinfonow.com/recall/73916-siemens-advia-centaur-calibrator-30-recall-negative-bias-in-estradiol · Updated September 23, 2026 · FDA enforcement record: FDA #Z-0515-2018
Cite this page
“Siemens ADVIA Centaur Calibrator 30 Recall: Negative Bias in Estradiol Testing.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/73916-siemens-advia-centaur-calibrator-30-recall-negative-bias-in-estradiol. Based on FDA recall #Z-0515-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0515-2018%22&limit=1).
Why it’s dangerous
The calibrator kits with lot numbers ending in 21 (C3021) can produce negative bias in estradiol (eE2) measurements compared to kits ending in 20 (C3020). This means test results may be too low, potentially leading to incorrect health decisions.
Who’s affected
Users of the ADVIA Centaur Calibrator 30 kits with specific lot numbers are affected. Laboratory staff and healthcare providers who use these kits for estradiol testing are most at risk.
How to tell if you have this one
Check the lot number on the calibrator kit packaging. Kits with lot numbers ending in 21 (e.g., 00387A21, 16673A21) are affected. The expiration date is March 8, 2018.
- Brand
Siemens Healthcare- Category
Medical device
What to do — step by step
Check Kit Lot Number
Look for lot numbers ending in 21 on the calibrator kit packaging.
How this recall unfolded
Recall timeline
FDA terminated this recall 23 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-0515-2018 (June 7, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0515-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.