Novocastra Lyophilized Mouse Monoclonal Antibody CD10 — Class II medical device recall Z-0341-2016
Terminated recall by Leica Microsystems, Inc., reported 2015-12-02, distributed nationwide. These Lot numbers are not stable up to the expiry date on the product labeling.
| Recall number | Z-0341-2016 |
|---|---|
| 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 | 2015-09-03 |
| Classified | 2015-11-25 |
| Reported by FDA | 2015-12-02 |
| Terminated | 2017-11-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BR, CA, CH, CN, CZ, DE, ES, FI, FR, GB, HU, ID, IE, IL, IT, JP, KR, NL, NO, RO, SE, SG, SI |
| Reason classes | labeling |
| Expiration dates | 2016-04, 2016-07, 2017-11 |
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 for recall
These Lot numbers 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-0341-2016. 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.