FDAClass IIApril 24, 2013

ADVIA Centaur Vitamin D Assay recall

ADVIA Centaur Vitamin D Assay (100 tests); Reference Number: 10491994. For use in the quantitative determination of Vit D.

Why was ADVIA Centaur Vitamin D Assay recalled?

Negative bias in patient samples for Vitamin D

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?

Ready Pack Lot Number: 134009 Kit Lot Number/Exp. Date: 88766009 4/28/2013 88786009 4/28/2013 89198009 4/28/2013 Ready Pack Lot Number: 134010 Kit Lot Number/Exp. Date: 90671010 6/2/2013 92212010 6/2/2013 Ready Pack Lot Number: 134011 Kit Lot Number/Exp. Date: 92395011 8/12/2013 94660011 8/12/2013 95016011 8/12/2013 95313011 8/12/2013

Product
ADVIA Centaur Vitamin D Assay (100 tests); Reference Number: 10491994. For use in the quantitative determination of Vit D.
Recalling firm
Siemens Healthcare Diagnostics, Inc
Quantity
3871
Distribution
Nationwide Distribution.
Recall date
April 24, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls