Reported Sep 23, 2020 · Terminated
Model No:T-SPOT.TB8, Catalogue No.: TB.300; UDI: 1505171600030 - Product Usage: intended for use as an aid in the…
Oxford Immunotec
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Oxford Immunotec · 94C Innovation Drive · Abingdon, N/A · N/A
Is this the product you have?
- Model No
T-SPOT.TB8Catalogue No.: TB.300
- UDI1505171600030 -
- Product Usageintended 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
- Lot codes and dates
- Manufacturing Kit Lot Numbers
TEC3321847TEC3041811
- Manufacturing Kit Lot Numbers
- Amount recalled
- 583 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Incorrect expiration date included in test kit labeling and/or in Substrate component label.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Oxford Immunotec recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.