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Recall Observatory FDA recall evidence

Device product

ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur, Centaur XP, Centaur CP Systems; Catalog Numbers: Cat No. 02816138/SMN 10309044 (100 test) 02816634/SMN 10309045 (500 test)

Z-0229-2015

October 06, 2014

Class III

Product summary

Firm
Siemens Healthcare Diagnostics, Inc
Event
Event 69461
Status
Terminated
Classification
Class III
Quantity
100 test - 4,600 kits; 500 test - 1,878 kits
Official record key
device-enforcement:Z-0229-2015

Official wording

Reason: Siemens Healthcare Diagnostics has confirmed that approximately 2000 ReadyPacks from the ADVIA Centaur¿ Systems BNP reagent contains an ADVIA Centaur Systems FT4 human-readable side label.

Code information: Lot 038174: 100 Test - 43305174 and 43278174; 500 Test - 43306174 and 43279174.

Distribution pattern: Worldwide Distribution - US Nationwide including Puerto Rico; and countries of: Canada, Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Fren.Polynesia, Germany, Great Britain, Greece, Guadeloupe, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Reunion, Russian Fed., Slovakia, Slovenia, Spain, Switzerland, Turkey, Unit.Arab Emir., AR, AU, BR, CL, CN, CR, IN, JP, KR, LK, MY, SG, TW, UY, VN, and ZA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Siemens Healthcare Diagnostics has confirmed that approximately 2000 ReadyPacks from the ADVIA Centaur¿ Systems BNP reagent contains an ADVIA Centaur Systems FT4 human-readable side label.