Remel Europe Ltd. FDA Recalls

2 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnosticsClass IIJul 17, 2026Certain lots of Neisseria meningitidis Gp C 2ml/VL, R3016690	Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive	Class IIDevices	Jul 17, 2026
Oxoid Agglutinating Sera, Salmonella 9-0 R30957301Class IIMar 25, 2026Affected lots are not performing to IFU criteria showing cro	Affected lots are not performing to IFU criteria showing cross reactions with 2-0 within 60 seconds. Cross-rea	Class IIDevices	Mar 25, 2026