FDAHealthJuly 17, 2026
Remel Europe Ltd. — Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics
⚠️ Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 17, 2026
US Nationwide distribution.
What's affected?
- Product
- Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics
- Brand
- Remel Europe Ltd.
- Lot code
- 6214791
Additional details
UDI/DI 05056080501161, Lot Numbers: 6214791, exp. 18/03/2025; 6175327, exp. 04/12/2027; 6148809, exp. 30/09/2027; 6002010, exp. 31/07/2027.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 26 units.
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