T-Spot.Tb Ref Tb.300 US recallZ-1641-2022 · Oxford Immunotec Ltd · initiated Jul 7, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Oxford Immunotec Ltd or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Storage
What the company is doing
On 07/07/2022, Oxford Immunotec Limited send a Field Safety Notice to customers informing them that the firm has become aware that products distributed may have been stored outside of the storage specifications for a short period. Customer are asked to quarantined the affected products until further notice. On 07/13/2022, the firm communicated a follow-up "URGENT ACTION REQUIRED" Letter to customer asking to confirm that affected products have been segregated into a quarantine area and have not been used to produce patient results. On 07/20/2022, the firm sent a "VOLUNTARY PRODUCT RECALL NOTIFICATION" informing customers that Oxford Immunotec Limited is conducting a full recall of the affected products and asking customers to now destroy the affected products following these steps: 1. Ensure Recalled Product remains in Quarantine. As per our previous communication dated July-13-2022, please ensure all stock of the above products remain in a secure location pending destruction. 2. Complete Tracking/Verification Form. Complete and return the enclosed tracking/verification form, following the directions on this page and the Tracking/Verification Form. Your Oxford Immunotec sales representative can assist you in completing the form. 3. Indicate Destroyed Products on Tracking/Verification Form. The tracking/verification form lists the [product name] and product descriptions. Please mark the number of each type of [product] that you are destroying on this form. On or after 08/03/2022, Oxford Immunotec Ltd communicated an updated/follow-up customer notification with included the potential risks/harms/hazards associated with the use of the affected products. For questions or assistance - contact Chris Dark at +44 1235 442780 or Maureen Garner at 855-NWRS-222 (855-697-7222), or alternatively any Oxford Immunotec Sales Representatives.
Recall details
- Recall number
- Z-1641-2022
- Status
- Open, Classified
- Initiated by the company
- Jul 7, 2022
- Recalling firm
- Oxford Immunotec Ltd
- Quantity
- 81 units
- Product code
- OJN
- Distribution
- U.S.: AL, CA, DC, GA, IN, OR, and WA O.U.S.: None
Product description
T-SPOT.TB REF TB.300 US
Code information (models, lots, serial numbers)
Model/Catalog Number: TB.300 US UDI-DI Code: 15051716000305 Lot Number: TEC4000098
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- T-SPOT®.TB8 TB.300Oxford Immunotec, Inc. · Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 90654).
- Z-1642-2022 · Open, ClassifiedT-Cell Xtend REF TTK.610 US
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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