FDA Device recall Z-0775-2014
Estrogen Receptor AB-11 (Clone ID5) Mouse Monoclonal Antibody 1 mk (2mg.ml) Manufactured by: Lab Vision Corporation, Fremont, CA Thermo Fis…
- FDA Device
- Class II
- terminated
- Published 2014-01-22
On 2014-01-22 the FDA classified a Class II recall of Estrogen Receptor AB-11 (Clone ID5) Mouse Monoclonal Antibody 1 mk (2mg.ml) Manufactured by: Lab Vision Corporation, Fremont, CA Thermo Fis… by Lab Vision, citing reports that the product is not performing as expected. In house testing showed no staining on breast cancer tissues.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0775-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-12-06 |
| Published | 2014-01-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Lab Vision |
| Distribution | US |
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
Reports that the product is not performing as expected. In house testing showed no staining on breast cancer tissues.
Identifiers
| code_info | PN/ MS-354-P0, LN 354P1206K; Expiration 03/2015. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0775-2014%22
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