EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4001

This recall has been terminated (originally issued December 23, 2005).

Company: Dakocytomation California Inc
Recall Initiated: October 14, 2005
Posted: December 23, 2005
Terminated: January 29, 2007
Recall Number: Z-0311-06
Quantity: Lots 045036=632, 065022=805 &, 085032=274
Firm Location: Carpinteria, CA
Official Source: View on FDA website ↗

Reason for Recall

This recall has been initiated due to a formulation error in the EnVision+ visualization reagent.

Distribution

Nationwide to: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MN, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, and WV. Worldwide to: Argentina, Bermuda, Brazil, Canada, Costa Rica, Denmark, Japan, Mexico, New Zealand, and Uruguay.