FDA Medical Device Recalls (openFDA)
OXFORD IMMUNOTEC LTD: T-SPOT.TB REF TB.300 US
- Recall number
- Z-1641-2022
- Recalling firm
- OXFORD IMMUNOTEC LTD
- Product
- T-SPOT.TB REF TB.300 US
- Status
- Open, Classified
- Initiated
- 2022-07-07
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Storage
- Action
- 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.
- Quantity
- 81 units
- Distribution
- U.S.: AL, CA, DC, GA, IN, OR, and WA O.U.S.: None
- Lot, serial or model codes
- Model/Catalog Number: TB.300 US UDI-DI Code: 15051716000305 Lot Number: TEC4000098
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OJN
- Firm FEI
- 3015492990
- Firm city
- Abingdon
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28