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Recall Observatory FDA recall evidence

Device product

Siemens ADVIA Centaur Multi-Diluent 1 - Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the ADVIA Centaur or ADVIA Centaur XP systems. Catalog Numbers: 2 Pack REF 07907174 (110312) 6 Pack REF 07293184 (110313). Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the ADVIA Centaur or ADVIA Centaur XP systems.

Z-2313-2012

July 25, 2012

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc
Event
Event 62702
Status
Terminated
Classification
Class II
Quantity
2 Packs = 15879 and 6 Packs = 7414
Official record key
device-enforcement:Z-2313-2012

Official wording

Reason: Decrease in onboard dilution recovery when using Multi-Diluent 1 that has been stored on board the ADVIA Centaur and ADVIA Centaur XP systems for for BNP and TSH3 Ultra assays

Code information: Lot # Expiry Date 2 Pack 76129 22 JUN 2012 77542 22 JUN 2012 78696 22 JUN 2012 80828 26 SEP 2012 80857 26 SEP 2012 81441 26 SEP 2012 82189 26 SEP 2012 83647 26 SEP 2012 84772 26 SEP 2012 86037 13 JAN 2013 86783 13 JAN 2013 88712 13 JAN 2013 90056 13 JAN 2013 91002 13 JAN 2013 93126 13 JAN 2013 6 Pack 76102 22 JUN 2012 76432 22 JUN 2012 77075 22 JUN 2012 78264 22 JUN 2012 79037 22 JUN 2012 81006 26 SEP 2012 82539 26 SEP 2012 83321 26 SEP 2012 84123 26 SEP 2012 85795 13 JAN 2013 86698 13 JAN 2013 88318 13 JAN 2013 89286 13 JAN 2013 90490 13 JAN 2013 91672 13 JAN 2013 93129 13 JAN 2013

Distribution pattern: Worldwide Distribution-USA (nationwide) and the countries of Canada, Argentina, Australia, Brazil, Chile, China, Croatia, Denmark, Ecuduar, Egypt,Guatemala, Hong Kong,India,Ireland, Israel,India, Japan,Korea, Mexico, Malyasia, Peru, Pakistan, Saudi Arabia,Singapore, Thailand,Uruguay, Viet Nam, and South Africa.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Decrease in onboard dilution recovery when using Multi-Diluent 1 that has been stored on board the ADVIA Centaur and ADVIA Centaur XP systems for for BNP and TSH3 Ultra assays