Agency classClass IIIOur severity:Low FDA (Devices)·Z-2977-2020·Announced 2020-09-23

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.

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 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…
Manufacturer: Oxford Immunotec
Category: Medical Device — Diagnostic Test Kit
Hazard: mis-labeling
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

Distributed nationwide across the United States.

The notice also names 11 states specifically:

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 →

Same manufacturer · Oxford Immunotec

See all →

Low
Oxford Immunotec Recalls T-SPOT.TB8 Kits Due to Incorrect Expiration Dates
FDA (Devices) · 2020-09-23

Same hazard · mis labeling