CLASS II Device recall · Reported 29 Oct 2014 · FDA Enforcement Report
Siemens Advia Centaur¿ Systems HBc Total (HBcT), Reagent recalled
Siemens Healthcare Diagnostics is recalling Siemens Advia Centaur¿ Systems HBc Total (HBcT), Reagent, distributed nationwide in the US. The recall was initiated on 15 Sep 2014 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-0102-2015
- FDA event ID
- 69292
- Recalling firm
- Siemens Healthcare Diagnostics, East Walpole, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Sep 2014
- FDA classified
- 21 Oct 2014
- Reported
- 29 Oct 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Hepatitis A
- Device type
- Test Kits & Diagnostics
Timeline
| 15 Sep 2014 | Recall initiated by company | |
| 21 Oct 2014 | Classified by FDA | +36 days |
| 29 Oct 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in initial reactive results.
Product as listed by the FDA
Siemens ADVIA Centaur¿ Systems HBc Total (HBcT), Reagent. For In Vitro Diagnostic Use Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBc Total) in human serum or plasma (potassium EDTA, or lithium or sodium heparinized) using the ADVIA Centaur and ADVIA Centaur XP system.
Where it was distributed
Worldwide Distribution-USA (nationwide) and the countries of Austria Bahrain Belgium Croatia Cyprus Czech Republic Denmark Estonia Finland France Germany Great Britain Greece Hungary Iraq Ireland Italy Jordan Latvia Lebanon Lithuania Luxembourg Netherlands Norway Poland Portugal Romania Slovakia Spain Sweden Switzerland Turkey Unit.Arab Emir and Yemen.
Questions about this recall
Is Siemens Advia Centaur¿ Systems HBc Total (HBcT), Reagent recalled?
Yes. Siemens Healthcare Diagnostics recalled Siemens Advia Centaur¿ Systems HBc Total (HBcT), Reagent on 15 Sep 2014. The recall is Class II and its status is Terminated. Recall number Z-0102-2015.
Why was it recalled?
Increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in initial reactive results.
Which lots are affected?
Lot Number: 100064 Exp.Date:February 10, 2015
Where was it sold?
Worldwide Distribution-USA (nationwide) and the countries of Austria Bahrain Belgium Croatia Cyprus Czech Republic Denmark Estonia Finland France Germany Great Britain Greece Hungary Iraq Ireland Italy Jordan Latvia Lebanon Lithuania Luxembourg Netherlands Norway Poland Portugal Romania Slovakia Spain Sweden Switzerland Turkey Unit.Arab Emir and Yemen.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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