Oxford Immunotec Recalls T-SPOT.TB8 Kits Due to Incorrect Expiration Dates
Oxford Immunotec is recalling 583 T-SPOT.TB8 test kits because they have incorrect expiration dates on the labeling.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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 documentation/labeling error regarding expiration dates.
Plain-English summary
Oxford Immunotec is recalling 583 units of the T-SPOT.TB8 test kit (Model No: T-SPOT.TB8, Catalogue No.: TB.300) due to incorrect expiration dates included in the test kit labeling and/or the Substrate component label. The affected manufacturing kit lot numbers are TEC3321847 and TEC3041811.
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 U.S. nationwide distribution in specific states and distribution in multiple international countries.
This recall is classified as Class III by the FDA, 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 instructions on return or replacement.
The recalled product
- 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 tuberculosis infection by detecting effector T cells that respond to stimulation by M. tuberculosis antigens ESAT-6 and CFP10, and…
- Manufacturer
- Oxford Immunotec
- Hazard
- Affected units
- 583
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 (2)
- Manufacturing Kit Lot Numbers: TEC3321847
- TEC3041811.
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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