Alinity i Anti-TPO Reagent Kit recall
Alinity i Anti-TPO Reagent Kit, List Number 09P3521
Why was Alinity i Anti-TPO Reagent Kit recalled?
Due to a manufacturing fill volume error, Alinity i Anti-TPO Reagent contains a marginally lower fill volume than detailed in the Kit Contents section of the Instructions for Use (IFU).
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 Number: (01)00380740153892(17)240720(10)46009FN00; List Number: 09P3521; Lot Number: 46009FN00; Expiration Date: 07/20/2024
- Product
- Alinity i Anti-TPO Reagent Kit, List Number 09P3521
- Recalling firm
- Abbott Ireland Limited
- Quantity
- 110 kits
- Distribution
- US Nationwide distribution in the states of CA, CO, FL, GA, IL, KY, LA, MD, MI, MN, NJ, NY, OH, RI, SC, SD, TN, TX, WA. No international distribution of affected lot.
- Recall date
- June 14, 2023
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (device)