OXFORD IMMUNOTEC LTD: Medical Device Recall in 2022 - (Recall #: Z-1641-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

T-SPOT.TB REF TB.300 US

Product Classification:

Class II

Date Initiated: July 7, 2022

Date Posted: September 7, 2022

Recall Number: Z-1641-2022

Event ID: 90654

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.

Status: Ongoing

Product Quantity: 81 units

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

Voluntary or Mandated:

Voluntary: Firm initiated