Device product
ADVIA Centaur¿¿ Systems HBc Total (HBcT) Kit. 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 EDT A, or lithium or sodium heparinized) using the ADVIA Centaur CP system.
Z-0103-2015
Product summary
- Event
- Event 69292
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5434
- Official record key
device-enforcement:Z-0103-2015
Official wording
Reason: Increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in initial reactive results.
Code information: Lot Number: 36217064, 36281064, 36449064, 37406064, 38177064 Exp.Date:February 10, 2015
Distribution pattern: 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.
Derived failure modes
-
Unknown
Increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in initial reactive results.