Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform… — Class II medical device recall Z-1315-2015
Terminated recall by Leica Microsystems, Inc., reported 2015-04-01, distributed nationwide. The staining intensity decreases over the shelf life.
| Recall number | Z-1315-2015 |
|---|---|
| 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 | 2014-12-16 |
| Classified | 2015-03-24 |
| Reported by FDA | 2015-04-01 |
| Terminated | 2017-09-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BR, CA, CH, CL, DE, DK, ES, FR, GB, HU, IN, IT, JP, NG, NL, PT, RO, RS, RU, SA, SE, SV, TN, TR, TW, ZA |
| Quantity | 309 units |
| Lot numbers | 2015-04, 2015-08, 2016-07, 6022274, 6024628, 6030581 |
Product
Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunohistochemical (IHC) staining. Product Usage: NCL-L-CD15 is intended for the qualitative identification by light microscopy of CD15 molecules in paraffin sections. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patients clinical history and other diagnostic tests by a qualified pathologist.
Reason for recall
The staining intensity decreases over the shelf life.
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-1315-2015. 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.