Z-0318-06

EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a...

Name: Z-0318-06 EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a...
Creator: Dakocytomation California Inc
Published: 2005-10-14
License: https://open.fda.gov/license/

Agilent Technologies, Inc. / initiated 2005-10-14 / Terminated

FDA source

Dakocytomation California Inc began a recall of EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a... on 2005-10-14. The reason FDA records is "This recall has been initiated due to a formulation error in the EnVision+ visualization reagent". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0318-06
Status: Terminated
Initiated: 2005-10-14
Posted: 2005-12-23
Terminated: 2007-01-29
Recalling firm: Agilent Technologies, Inc.
Product: 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 K4009
Product code: NJT Immunohistochemistry Reagents And Kits
Reason for recall: This recall has been initiated due to a formulation error in the EnVision+ visualization reagent.
FDA root cause: Other
Action: Notification letter dated October 14, 2005 was sent by certified mail to cosignees instructing dosposal of product.
Quantity in commerce: Lots 045175=14, 065144=6 &, 085147=0
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.
Product codes and lots: K4009: Lots 045175, 065144, 085147

Product code NJT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)