FDA Device recall Z-0341-2016
Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10)
- FDA Device
- Class II
- terminated
- Published 2015-12-02
On 2015-12-02 the FDA classified a Class II recall of Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10) by Leica Microsystems, citing these Lot numbers are not stable up to the expiry date on the product labeling.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0341-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-09-03 |
| Published | 2015-12-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Leica Microsystems |
| Distribution | US |
Product
Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10). Immunohistochemistry. in vitro diagnostic. 0.1ml NCL-CD10-270 and 1mL NCL-CD10-270 are intended for the qualitative identification by light microscopy of CD10 molecules in paraffin sections.
Reason
These Lot numbers are not stable up to the expiry date on the product labeling.
Identifiers
| code_info | CD10-270-CE-S (0.1 ml) 6033086 (U.S. Distribution) expire 06/2016, 6032390 expires 04/2016, 6033622 expires 07/2016.…CD10-270-CE-S (0.1 ml) 6033086 (U.S. Distribution) expire 06/2016, 6032390 expires 04/2016, 6033622 expires 07/2016. CD10-270-CE (1ml) 6032742 (U.S. Distribution) expires 11/2017. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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All Leica Microsystems recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0341-2016%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.