Bond Polymer Refine Red Detection DS9390 kits. The common name of the device is detection system for in vitro diagnostic use. The Intended Use states that Bond Polymer Refine Red Detection is a biotin-free, polymeric alkaline phosphatase (AP)-linker antibody conjugate system for the detection of tissue-bound mouse and rabbit IgG and some mouse IgM primary antibodies. It is intended for staining sections of formalin-fixed, paraffin-embedded tissue on the BOND automated system.
This recall has been terminated (originally issued February 12, 2016).
- Company
- Leica Microsystems, Inc.
- Recall Initiated
- November 27, 2015
- Posted
- February 12, 2016
- Terminated
- January 5, 2017
- Recall Number
- Z-0808-2016
- Quantity
- 3745
- Firm Location
- Buffalo Grove, IL
- Official Source
- View on FDA website ↗
Reason for Recall
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.
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.
Lot / Code Info
Product Code DS9390 with lot numbers 41203, 41407, 41478, 41575, 41619, 41779, 41872, 42027, 42105, 42172, 42181, 42251, 42345, 42397, 42512 and 42594.
Root Cause
Mixed-up of materials/components
Action Taken
Leica Biosystems sent an Urgent Medical Device Recall Notice dated November 30, 2015, to all affected customer. The letter identified the product the problem and the action needed to be taken by the customer. Do not use or continue to use the reagent lots listed above, as they have the potential to result in inadequate tissue staining and lead to weak or false negative pathology results. Please also properly destroy any unused or partially used affected lots of the reagent, and indicate by signing and returning the attached Medical Device Recall Acknowledgement Form that this action has been undertaken. As indicated in the Instructions for Use, the clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patients clinical history and other diagnostic tests by a qualified pathologist. The consignees are requested to consult with their laboratory director and physician to determine whether a review of past results obtained from the affected lots is clinically warranted. Direct accounts are requested to forward the notice primarily to the end users where the product has been sold and to all those within the organization who need to be aware of this issue. Periodic effectiveness checks will be conducted to address non responders. For further questions please call ( 847) 405-5413