ADVIA Centaur aTPO Assay recall
ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)
Why was ADVIA Centaur aTPO Assay recalled?
Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the table below when compared to alternate lots on the Atellica IM analyzer.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
UDI-DI: Material Number 10630886 (100 Test) - 00630414587837; Material Number 10630887 (500 Test) - 00630414587844; Lot Number: 26053337 26054337 26051337 26052337
- Product
- ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 5622 kits
- Distribution
- Worldwide distribution - US Nationwide.
- Recall date
- October 9, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)