- Recalling firm
- Remel Europe Ltd.
- 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.
- Affected products (lot / model / serial)
- 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.
- Units affected
- 26 units
- Distribution pattern
- US Nationwide distribution.
- Firm location
- Dartford, United Kingdom
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2927-2026
- Recall initiated
- July 17, 2026
- FDA classification date
- August 7, 2026
- FDA report date
- August 19, 2026
- FDA event ID
- 99450
- Last updated on HTM Vibe
- August 26, 2026