Recall Z-2976-2020— Oxford Immunotec
Class III · Terminated
Class III FDA medical device recall by Oxford Immunotec, initiated 2020-07-16, terminated 2021-09-13. FDA's recall record names no specific 510(k) clearance for this event. Product: Model No:T-SPOT.TB8, Catalogue No.: TB.300; UDI: 1505171600030 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulation by M. tuberculosis antigens ESAT-6 and CFP10, and capturing interferon-gamma in the vicinity of these cells.. Reason: Incorrect expiration date included in test kit labeling and/or in Substrate component label..
- Recalling firm
- Oxford Immunotec
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2020-07-16
- Terminated
- 2021-09-13
- Firm location
- Abingdon, N/A, United Kingdom
Product description
Model No:T-SPOT.TB8, Catalogue No.: TB.300; UDI: 1505171600030 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulation by M. tuberculosis antigens ESAT-6 and CFP10, and capturing interferon-gamma in the vicinity of these cells.
Reason for recall
Incorrect expiration date included in test kit labeling and/or in Substrate component label.
Data sourced from openFDA. This site is unofficial and independent of the FDA.