FDAFDA · Food and drugs·Recall number Z-0102-2015
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.
Published October 29, 2014 · Recall initiated: September 15, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in initial reactive results.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Distributor
- 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.
- Lot
- Lot Number: 100064 Exp.Date:February 10, 2015
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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