REPLIGEN CORPORATION

FDA Regulatory Profile

REPLIGEN CORPORATION appears in FDA public data with 1 recall, 0 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1024-2026, Class II) was initiated on December 10, 2025.

Summary

Total Recalls
1
510(k) Clearances
0
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1024-2026Class IIMAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) FinisDecember 10, 2025