Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86003

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 16, 2020
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Oxford Immunotec

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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 capturing interferon-gamma in the vicinity of these cells.

Z-2976-2020
Recall number
Z-2976-2020
Initiated
July 16, 2020
Classification
Class III
Status
Terminated
Recalling firm
Oxford Immunotec
Quantity
583 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Incorrect expiration date included in test kit labeling and/or in Substrate component label.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Manufacturing Kit Lot Numbers: TEC3321847, TEC3041811.

Distribution pattern

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.

device · product 2 of 2

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 capturing interferon-gamma in the vicinity of these cells.

Z-2977-2020
Recall number
Z-2977-2020
Initiated
July 16, 2020
Classification
Class III
Status
Terminated
Recalling firm
Oxford Immunotec
Quantity
125 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Incorrect expiration date included in test kit labeling and/or in Substrate component label.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Manufacturing Kit Lot Numbers: TFC2481752, TFC2621768, TFC2661790, TFC3081816, TFC3101817, TFC3111818, TFC3111825, TFC2621885, TFC2471883, TFC3361860.

Distribution pattern

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.