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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90654

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

Open FDA event record

Event summary

Timeline bucket
July 07, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
OXFORD IMMUNOTEC LTD

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

3 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 3

T-SPOT.TB REF TB.300 US

Z-1641-2022
Recall number
Z-1641-2022
Initiated
July 07, 2022
Classification
Class II
Status
Ongoing
Recalling firm
OXFORD IMMUNOTEC LTD
Quantity
81 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to equipment failure, affected products were stored at temperatures outside the validated range of 2-8 degree C for a period longer than the validated storage time.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to equipment failure, affected products were stored at temperatures outside the validated range of 2-8 degree C for a period longer than the validated storage time.

Code information

Model/Catalog Number: TB.300 US UDI-DI Code: 15051716000305 Lot Number: TEC4000098

Distribution pattern

U.S.: AL, CA, DC, GA, IN, OR, and WA O.U.S.: None

device · product 2 of 3

T-Cell Xtend REF TTK.610 US

Z-1642-2022
Recall number
Z-1642-2022
Initiated
July 07, 2022
Classification
Class II
Status
Ongoing
Recalling firm
OXFORD IMMUNOTEC LTD
Quantity
47 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to equipment failure, affected products were stored at temperatures outside the validated range of 2-8 degree C for a period longer than the validated storage time.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to equipment failure, affected products were stored at temperatures outside the validated range of 2-8 degree C for a period longer than the validated storage time.

Code information

Model/Catalog Number: TTK.610 US UDI-DI Code: 15051716000022 Lot Number: 1001

Distribution pattern

U.S.: AL, CA, DC, GA, IN, OR, and WA O.U.S.: None

device · product 3 of 3

AIM-V Medium REF AV.200/500

Z-1643-2022
Recall number
Z-1643-2022
Initiated
July 07, 2022
Classification
Class II
Status
Ongoing
Recalling firm
OXFORD IMMUNOTEC LTD
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to equipment failure, affected products were stored at temperatures outside the validated range of 2-8 degree C for a period longer than the validated storage time.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to equipment failure, affected products were stored at temperatures outside the validated range of 2-8 degree C for a period longer than the validated storage time.

Code information

Model/Catalog Number: AV.200/500 UDI-DI Code: Not yet assigned Lot Number: 100380

Distribution pattern

U.S.: AL, CA, DC, GA, IN, OR, and WA O.U.S.: None