FDA Device recall Z-1876-2016
Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) is recommended for use as part of a panel of antibodies in the…
- FDA Device
- Class II
- terminated
- Published 2016-06-08
On 2016-06-08 the FDA classified a Class II recall of Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) is recommended for use as part of a panel of antibodies in the… by Leica Microsystems, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1876-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-05 |
| Published | 2016-06-08 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Leica Microsystems |
| Distribution | AR, CA, CT, FL, ID, IL, IN, MT, OH, PA, TN, TX |
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
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.
Identifiers
| code_info | 1ml size Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) with lot numbers 6036120, 6032345 and 6023543. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1876-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.