The Recall Desk

FDA (Devices) recall action 86003

Oxford Immunotec recalled 2 products on 2020-09-23

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2020-09-23
Critical
0
Units
708

Why these products were recalled

Incorrect expiration date included in test kit labeling and/or in Substrate component label.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • LowFDA (Devices)··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.

    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
    Category
    Distribution
    11 states
  • LowFDA (Devices)··2020-09-23

    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.

    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 capturin
    Category
    Distribution
    11 states