Remel Europe Ltd.

FDA Regulatory Profile

Remel Europe Ltd. appears in FDA public data with 3 recalls, 0 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2927-2026, Class II) was initiated on July 17, 2026.

Summary

Total Recalls
3
510(k) Clearances
0
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2927-2026Class IIThermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagJuly 17, 2026
Z-1923-2026Class IIOxoid Agglutinating Sera, Salmonella 9-0 R30957301March 25, 2026
Z-2920-2020Class IIThermo Scientific Remel Bordetella pertussis Agglutinating Serum Product Number: R30165501, UDI-DI: July 23, 2020