This reagent is for in vitro diagnostic use — Class II medical device recall Z-0823-2016
Terminated recall by Leica Microsystems, Inc., reported 2016-03-02, distributed in AR, AZ, CA, CO, CT, DC, DE, FL…. The Bond" Polymer Refine Detection and Novolink" Polymer Detection System may not provide adequate staining wh
| Recall number | Z-0823-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Leica Microsystems, Inc., Buffalo Grove, IL, United States |
| Recall initiated | 2015-12-30 |
| Classified | 2016-02-19 |
| Reported by FDA | 2016-03-02 |
| Terminated | 2017-01-05 |
| Distributed | 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, WV |
| Countries outside the US | AE, AR, AU, BG, BR, CH, CL, CN, DE, EC, EG, ES, FI, FR, GB, GR, IN, IT, JO, JP, KR, KW, LB, MY, PH, PL, PT, RO, SE, SG, SV, TH, TN, TR |
| Quantity | 1,700 units |
| Lot numbers | 42314, 42388, 42474, 42486, 42499, 42555, 42570, 42579, 42627, 42645, 42683, 42780, 42802, 42823, 42852, 43050 |
Product
This reagent is for in vitro diagnostic use. Pax-5 (1EW) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Pax-5 in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated Bond system.
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 Block is applied after the primary marker incubation as specified in the Instructions for Use Following the Instructions for Use.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0823-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.