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Terminated

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

FDA Recall Z-0320-06 · Posted 2005-12-23

Recalling FirmDakocytomation California Inc
Recall StatusTerminated
Product CodeNJT
Date Initiated2005-10-14
Date Terminated2007-01-29
Product QuantityLots 035196=163, 055032=168 &, 075115=124

Reason for Recall

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

Firm Action

Notification letter dated October 14, 2005 was sent by certified mail to cosignees instructing dosposal of product.

Root Cause

Other

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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