Home / Recalls / OXFORD IMMUNOTEC LTD / Z-1641-2022

Z-1641-2022 Class II Ongoing

Recalled by OXFORD IMMUNOTEC LTD — Abingdon

Recall Details

Product Type
Devices
Report Date
September 7, 2022
Initiation Date
July 7, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
81 units

Product Description

T-SPOT.TB REF TB.300 US

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.

Distribution Pattern

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

Code Information

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

Other recalls by OXFORD IMMUNOTEC LTD

  • Z-1643-2022 Class II — AIM-V Medium REF AV.200/500 (July 7, 2022)
  • Z-1642-2022 Class II — T-Cell Xtend REF TTK.610 US (July 7, 2022)
  • Z-2976-2020 Class III — Model No:T-SPOT.TB8, Catalogue No.: TB.300; UDI: 1505171600030 - Product Usage: (July 16, 2020)
  • Z-2977-2020 Class III — Model No:T-SPOT.TB50, Catalogue No.: TB.50; UDI: 1505171600004 - Product Usage: (July 16, 2020)