Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics
Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics
Recalling Firm: Remel Europe Ltd.
Reason for Recall / Hazard
Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds.
Product Description & Identification
Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics
Additional Source Details
| Field | Value |
|---|---|
| City | Dartford |
| Event id | 99450 |
| Address 1 | Clipper Boulevard West |
| Address 2 | Ken |
| Code info | 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. |
| Postal code | N/A |
| Report date | 20260819 |
| Product type | Devices |
| Product quantity | 26 units |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260717 |
| Initial firm notification | Letter |
| Center classification date | 20260807 |
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Overview
- Recalling FirmRemel Europe Ltd.
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution.
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🚨 SAFETY ALERT: Remel Europe Ltd. - Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics Check if your household is affected: https://therecallfile.com/recalls/thermo-fisher-diagnostics-neisseria-meningitidis-gp-c-2ml-vl-product-n/FDA-Z-2927-2026
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