ADVIA Centaur¿ DHEA-SO4 recall
ADVIA Centaur¿ DHEA-SO4
Why was ADVIA Centaur¿ DHEA-SO4 recalled?
The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly state the level at which biotin does not interfere
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?
ADVIA Centaur¿ DHEA-SO4; radioimmunoassay, dehydroepiandrosterone (free and sulfate); SMN 10282227 ADVIA Centaur DHEA-S Kit Lot # 00119053 14041053 80449053 90520053 29750054 30423054 39155054 50533054 63267055 68936055 79273055 86427055 06402057 07109057 14187057 37499057
- Product
- ADVIA Centaur¿ DHEA-SO4
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- N/A
- Distribution
- Nationwide and Canada, Mexico, and Thailand
- Recall date
- May 16, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)