Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL — Class II medical device recall Z-2927-2026
Ongoing recall by Remel Europe Ltd., reported 2026-08-19, distributed nationwide. Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive
| Recall number | Z-2927-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Remel Europe Ltd., Dartford, United Kingdom |
| Recall initiated | 2026-07-17 |
| Classified | 2026-08-07 |
| Reported by FDA | 2026-08-19 |
| Distributed | Nationwide (US) |
| Quantity | 26 units |
| UPC / GTIN / UDI-DI | 05056080501161 |
| Lot numbers | 6002010, 6148809, 6175327, 6214791 |
| Expiration dates | 2027-04-12 |
Product
Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics
Reason for recall
Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2927-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.