Z-0823-2016 Class II Terminated
FDA device recall Z-0823-2016 was initiated by Leica Microsystems, Inc. on Dec 30, 2015 and is designated Class II. Reason for recall: The Bond" Polymer Refine Detection and Novolink" Polymer Detection System may not provide adequate staining when using a detection protocol where one of its components - Peroxide Block / Peroxidase… The recall status is terminated (terminated Jan 5, 2017). Affected quantity: 1700 units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 2, 2016
- Initiation Date
- Dec 30, 2015
- Termination Date
- Jan 5, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1700 units
Product Description
Reason for Recall
Distribution Pattern
US Consignees incluude: AR ,AZ ,CA ,CO ,CT ,DC ,DE ,FL ,GA ,HI ,IA ,IL ,KY ,LA ,MA ,MD ,MI ,MN ,MO ,MT ,NC ,NH ,NJ ,NY ,OH ,OK ,PA ,PR ,SC ,TN ,TX ,UT ,VA ,VT ,WA ,WI and WV. Foreign Consignees include:Argentina , Australia , Brazil , Bulgaria , Chile , China , Ecuador ,Egypt , El Salvador , Finland , France , Georgia , Germany , Greece , India , Italy , Japan , Jordan , Kuwait , Lebanon , Malaysia , Philippines , Poland , Portugal , Romania , Russian Fed. , Singapore , South Korea , Spain , Sweden , Switzerland , Thailand , Tunisia , Turkey , United Kingdom and United Arab Emirates.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0823-2016
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026