Class II — Lab Vision Corporation
| Recalling firm | Vision Lab Co, LLC |
|---|---|
| Registered facility | VISION LAB CO, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Reports that the product is not performing as expected. In house testing showed no staining on breast cancer tissues. |
| 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. |
| Quantity | 5 |
| Distribution | Worldwide Distribution: US (nationwide) including the states of TX and MA and internationally to: Turkey. |
| Initiated | 2013-12-06 |
| Classified | 2014-01-16 |
| Terminated | 2014-02-25 |
| Recall number | Z-0775-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Lab Vision Corporation (Z-0775-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67065/
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