FDAClass IISeptember 12, 2012

Siemens ADVIA Centaur Multi-Diluent 1 - Used for recall

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…

Why was Siemens ADVIA Centaur Multi-Diluent 1 - Used for recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
Siemens Healthcare Diagnostics, Inc
Quantity
2 Packs = 15879 and 6 Packs = 7414
Distribution
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.
Recall date
September 12, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls