EnVision FLEX/HRP visualization reagent found in the recall
EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX…
Why was EnVision FLEX/HRP visualization reagent found in the recalled?
There is a defect in one lot of a buffer, non-specific background staining that has, in some instances, interfered with interpretation of the staining results.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Item No.: K800021-2, K800221-2, K802321-2 (Link) K801021-2, K801221-2, K802421-2 (AS/AS+) GV80011-2, GV82311-2 (Dako Omnis) Catalog/Model No.: K8000 K8002 K8023 GV800 SM802 EnVision FLEX / HRP Lot 20019374 used in: Envision FLEX, High pH (link) Lot No.: 20019097, 20020777, 20021381 Envision FLEX+, Mouse, High pH (link) Lot No.: 20019103, 20019113, 20020772 EnVision FLEX Mini Kit, High pH (Link) Lot No.: 20021362 DM 842 EnVision FLEX / HRP (Dako Omnis) Lot 20019013 used in: EnVision FLEX, High pH (Dako Omnis) Lot No.: 20019102
- Product
- EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX…
- Recalling firm
- Dako North America Inc.
- Quantity
- 300 units
- Distribution
- Worldwide Distribution - US (nationwide) Distribution including Puerto Rico and to the states of : TX, SD, CA, FL, MA, MD, WV, NC, OH, DE, MI, NJ, CO, HI, AR, NY, LA, GA, NV, RI, IL, OK, CT, MO, VA, and DC., and to the countries of : Canada, Brazil and Costa Rica.
- Recall date
- November 11, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)