Official recall notice
FDA DeviceClass IINotable
FDA Recall: Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diag
- Recall date
- 2026-08-19
- Brand
- Remel Europe Ltd.
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds.
Recommended action
What to do
26 units
Product description
Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds.