Atellica IM aTPO Assay recall
Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)
Why was Atellica IM 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 10995466 (100 Test) - 00630414597935; Material Number 10995467 (500 Test) - 00630414597942; Lot Number: 26098336 26099336
- Product
- Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 9783 kits
- Distribution
- Worldwide distribution - US Nationwide.
- Recall date
- October 9, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)