Estrogen Receptor AB-11 — Class II medical device recall Z-0775-2014
Terminated recall by Lab Vision Corporation, reported 2014-01-22, distributed nationwide. Reports that the product is not performing as expected. In house testing showed no staining on breast cancer t
| Recall number | Z-0775-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lab Vision Corporation, Fremont, CA, United States |
| Recall initiated | 2013-12-06 |
| Classified | 2014-01-16 |
| Reported by FDA | 2014-01-22 |
| Terminated | 2014-02-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | TR |
| Quantity | 5 |
| Expiration dates | 2015-03 |
Product
Estrogen Receptor AB-11 (Clone ID5) Mouse Monoclonal Antibody 1 mk (2mg.ml) Manufactured by: Lab Vision Corporation, Fremont, CA Thermo Fisher Scientific Anatomical Pathology Tudor Rd., Manor Park Rancorn, Cheshire WA7 1TA UK Analyte specific reagent. It is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin embedded tissue sections, to be viewed by light microscopy.
Reason for recall
Reports that the product is not performing as expected. In house testing showed no staining on breast cancer tissues.
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-0775-2014. 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.