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U.S. Department of Health and Human Services

Class 2 Device Recall EnVision Model Number K4011

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 Class 2 Device Recall EnVision Model Number K4011see related information
Date Initiated by FirmOctober 14, 2005
Date PostedDecember 23, 2005
Recall Status1 Terminated 3 on January 29, 2007
Recall NumberZ-0320-06
Recall Event ID 33957
Product Classification Immunohistochemistry Reagents And Kits - Product Code NJT
ProductEnVision+, 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 K4011
Code Information K4011: Lots 035196, 055032, 075115
Recalling Firm/
Manufacturer
Dakocytomation California Inc
6392 Via Real
Carpinteria CA 93013-2921
For Additional Information ContactScot D. Kinghorn
805-566-5478
Manufacturer Reason
for Recall
This recall has been initiated due to a formulation error in the EnVision+ visualization reagent.
FDA Determined
Cause 2
Other
ActionNotification letter dated October 14, 2005 was sent by certified mail to cosignees instructing dosposal of product.
Quantity in CommerceLots 035196=163, 055032=168 &, 075115=124
DistributionNationwide 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.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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