Device recall

Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics

FDA recall source

Recall number

Z-2927-2026

Event id

99450

Status

Ongoing

FDA classification

Class II

Recalling firm

Remel Europe Ltd.

Report date

Aug 19, 2026

Initiated

Jul 17, 2026

Center classification date

Aug 7, 2026

Reason

Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds.

Quantity

26 units

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.

Distribution

US Nationwide distribution.

Voluntary or mandated

Voluntary: Firm initiated

Location

Dartford, United Kingdom