Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker — Class II medical device recall Z-1876-2016
Terminated recall by Leica Microsystems, Inc., reported 2016-06-08, distributed in AR, CA, CT, FL, ID, IL, IN, MT…. Testing of retained units indicated that Lot numbers of CDX2 and RCC indicated are not stable up to the expiry
| Recall number | Z-1876-2016 |
|---|---|
| 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 | 2016-04-05 |
| Classified | 2016-06-01 |
| Reported by FDA | 2016-06-08 |
| Terminated | 2017-11-30 |
| Distributed | AR, CA, CT, FL, ID, IL, IN, MT, OH, PA, TN, TX |
| Countries outside the US | CA |
| Quantity | 270 units |
| Reason classes | labeling |
| Lot numbers | 6023543, 6032345, 6036120 |
Product
Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) is recommended for use as part of a panel of antibodies in the definition of tumors of proximal nephrogenic differentiation.
Reason for recall
Testing of retained units indicated that Lot numbers of CDX2 and RCC indicated are not stable up to the expiry date on the product labeling.
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-1876-2016. 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.