EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in variou
FDA device recall Z-0316-06 · posted 2005-12-23 · Terminated
Recall details
- Recalling firm
- Dakocytomation California Inc
- Reason for recall
- This recall has been initiated due to a formulation error in the EnVision+ visualization reagent.
- Action taken
- Notification letter dated October 14, 2005 was sent by certified mail to cosignees instructing dosposal of product.
- Root cause
- Other
- Status
- Terminated
- Product code
- NJT
- Quantity affected
- Lots 045173=961& 075113=313
- 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,
- Date initiated
- 2005-10-14
- Date posted
- 2005-12-23
- Date terminated
- 2007-01-29
- Location
- Carpinteria, CA
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