CLASS II Device recall · Reported 5 Nov 2014 · FDA Enforcement Report
Advia Centaur Calibrator C-Used recalled
Siemens Healthcare Diagnostics is recalling Advia Centaur Calibrator C-Used with the Advia Centaur Ferritin assay on the Advia, distributed nationwide in the US. The recall was initiated on 9 Oct 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0129-2015
- FDA event ID
- 69449
- Recalling firm
- Siemens Healthcare Diagnostics, East Walpole, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Oct 2012
- FDA classified
- 24 Oct 2014
- Reported
- 5 Nov 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 9 Oct 2012 | Recall initiated by company | |
| 24 Oct 2014 | Classified by FDA | +745 days |
| 5 Nov 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 06567787 (6 pack)
Where it was distributed
Worldwide Distribution - Nationwide Distribution and the countries of Argentina, Australia, Brazil, Canada, China, Columbia, Egypt, Hong Kong, India, Israel, Indoenesia, India, Japan, Korea, Mexico, Malaysia, Philippines, Saudi Arabia, Singapore, Taipei, Uruguay, Venezuela, Viet Nam and South Africa.
Questions about this recall
Why was it recalled?
Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system
Which lots are affected?
Lot numbers: 82069A22 Exp Date: 01/19/2013 82946A22 84494A22 85340A22 85804B22 87430B22 90884B22 95232A23 Exp. Date: 10/16/2013 95589A23 96012A23
Where was it sold?
Worldwide Distribution - Nationwide Distribution and the countries of Argentina, Australia, Brazil, Canada, China, Columbia, Egypt, Hong Kong, India, Israel, Indoenesia, India, Japan, Korea, Mexico, Malaysia, Philippines, Saudi Arabia, Singapore, Taipei, Uruguay, Venezuela, Viet Nam and South Africa.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 69449This product is part of a recall event; the main page for the event is Advia Centaur Calibrator C-Used recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Advia Centaur Calibrator C-Used recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide | |
| CLASS II | Advia Centaur Ferritin Calibrator C-Used recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |
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