Bond Polymer recall
Bond Polymer Refine Red Detection DS9390 kits. The common name of the device is detection system for in vitro diagnostic use. The Intended Use…
Why was Bond Polymer recalled?
The Firm informed the importer/distributor, Leica Microsystems, a manufacturing error occurred during the filling of some containers of the Bond Polymer Refine Red Detection DS9390 kits, which may result in inadequate staining.
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?
Product Code DS9390 with lot numbers 41203, 41407, 41478, 41575, 41619, 41779, 41872, 42027, 42105, 42172, 42181, 42251, 42345, 42397, 42512 and 42594.
- Product
- Bond Polymer Refine Red Detection DS9390 kits. The common name of the device is detection system for in vitro diagnostic use. The Intended Use…
- Recalling firm
- Leica Microsystems, Inc.
- Quantity
- 3745
- Distribution
- Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Argentina, Australia, Austria, Belgium, Chile, Denmark, France, Germany, Greece, Hong Kong, Italy, Japan , Netherlands, Romania Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey and UK.
- Recall date
- February 24, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)