| Class 2 Device Recall EnVision Model Number K4011 | |
Date Initiated by Firm | October 14, 2005 |
Date Posted | December 23, 2005 |
Recall Status1 |
Terminated 3 on January 29, 2007 |
Recall Number | Z-0320-06 |
Recall Event ID |
33957 |
Product Classification |
Immunohistochemistry Reagents And Kits - Product Code NJT
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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 K4011 |
Code Information |
K4011: Lots 035196, 055032, 075115 |
Recalling Firm/ Manufacturer |
Dakocytomation California Inc 6392 Via Real Carpinteria CA 93013-2921
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For Additional Information Contact | Scot 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 |
Action | Notification letter dated October 14, 2005 was sent by certified mail to cosignees instructing dosposal of product. |
Quantity in Commerce | Lots 035196=163, 055032=168 &, 075115=124 |
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.
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Total Product Life Cycle | TPLC Device Report |
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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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