Class II — Remel Europe Ltd.
| Recalling firm | Remel Europe Ltd. |
|---|---|
| Classification | Class II |
| Status | Ongoing |
| Reason | Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds. |
| Product | Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics |
| Quantity | 26 units |
| Distribution | US Nationwide distribution. |
| Initiated | 2026-07-17 |
| Classified | 2026-08-07 |
| Recall number | Z-2927-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Remel Europe Ltd. (Z-2927-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99450/
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