Recall Z-0311-06 ยท NJT Immunohistochemistry Reagents And Kits
Dakocytomation California Inc
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
| Date | Dec 23, 2005 (initiated Oct 14, 2005) |
| Status | Terminated |
| Reason | This recall has been initiated due to a formulation error in the EnVision+ visualization reagent. |
| Root cause | Other |
| Action | Notification letter dated October 14, 2005 was sent by certified mail to cosignees instructing dosposal of product. |
| Quantity | Lots 045036=632, 065022=805 &, 085032=274 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.