Oxford Immunotec T-SPOT.TB50 Tuberculosis Test Kits Recalled for Labeling Error
Oxford Immunotec is recalling T-SPOT.TB50 tuberculosis test kits due to incorrect expiration dates on the test kit and substrate labels.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The specific defect is a labeling error regarding expiration dates.
Plain-English summary
Oxford Immunotec is recalling 125 units of the T-SPOT.TB50 tuberculosis test kit (Catalogue No.: TB.50) because of incorrect expiration dates included in the test kit labeling and/or the Substrate component label. The affected manufacturing kit lot numbers are TFC2481752, TFC2621768, TFC2661790, TFC3081816, TFC3101817, TFC3111818, TFC3111825, TFC2621885, TFC2471883, and TFC3361860.
The product is intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulation by M. tuberculosis antigens ESAT-6 and CFP10. The recall covers worldwide distribution, including nationwide distribution in the United States and distribution in Austria, Belgium, Czech Republic, France, Germany, Italy, Kuwait, Latvia, Netherlands, Philippines, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Turkey, and the United Kingdom.
The U.S. Food and Drug Administration has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. Consumers and healthcare providers should stop using the affected kits and contact the manufacturer for further instructions.
The recalled product
- Product
- Model No:T-SPOT.TB50, Catalogue No.: TB.50; UDI: 1505171600004 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulation by M. tuberculosis antigens ESAT-6 and CFP10, and capturin
- Manufacturer
- Oxford Immunotec
- Hazard
- Affected units
- 125
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- Manufacturing Kit Lot Numbers: TFC2481752
- TFC2621768
- TFC2661790
- TFC3081816
- TFC3101817
- TFC3111818
- TFC3111825
- TFC2621885
- TFC2471883
- TFC3361860.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Oxford Immunotec under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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