Model No:T-SPOT.TB8 recall: Labeling Error
Model No:T-SPOT.TB8, Catalogue No.: TB.300; UDI: 1505171600030 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium…
Why was Model No:T-SPOT.TB8 recalled?
Incorrect expiration date included in test kit labeling and/or in Substrate component label.
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?
Manufacturing Kit Lot Numbers: TEC3321847, TEC3041811.
- Product
- Model No:T-SPOT.TB8, Catalogue No.: TB.300; UDI: 1505171600030 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium…
- Recalling firm
- Oxford Immunotec
- Quantity
- 583 units
- Distribution
- Worldwide distribution - U.S. Nationwide distribution including in the states of AL, CO, D.C., GA, ID, IN, MD, OH, PA, TN, TX, and VA. The countries of Austria, Belgium, Czech Republic, France, Germany, Italy, Kuwait, Latvia, Netherlands, Philippines, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Turkey, United Kingdom.
- Recall date
- September 23, 2020
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)