Remel Europe Ltd.: Antisera, All Groups, N. Meningitidis
- Recalling firm
- Remel Europe Ltd.
- Product
- Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics
- Reason
- Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-07-17
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/463462bd-10d5-4ac4-a28e-be013204f24b