T-spot.tb recall
T-SPOT.TB REF TB.300 US
Why was T-spot.tb recalled?
Due to equipment failure, affected products were stored at temperatures outside the validated range of 2-8 degree C for a period longer than the validated storage time.
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?
Model/Catalog Number: TB.300 US UDI-DI Code: 15051716000305 Lot Number: TEC4000098
- Product
- T-SPOT.TB REF TB.300 US
- Recalling firm
- OXFORD IMMUNOTEC LTD
- Quantity
- 81 units
- Distribution
- U.S.: AL, CA, DC, GA, IN, OR, and WA O.U.S.: None
- Recall date
- September 7, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)