Bion Enterprises Ltd

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
0
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1479-2013Class IIIPlastic bottle containing 3.5 mL of IgG FITC Conjugate Product Usage: Product is a used as a couJanuary 23, 2013
Z-1477-2013Class IIIPlastic bottle containing 10.5 mL of IgG Conjugate Product Usage: Product is a used as a counterJanuary 23, 2013
Z-1478-2013Class IIIPlastic bottle containing 10.5 mL of IgM Conjugate Product Usage: Product is a used as a counterJanuary 23, 2013