Lab Vision Estrogen Receptor Antibody Recalled for Performance Issues
Lab Vision Corporation is recalling Estrogen Receptor AB-11 antibody because in-house testing showed no staining on breast cancer tissues.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a performance defect (lack of staining) rather than a direct physical injury or contamination, fitting the criteria for moderate severity.
Plain-English summary
Lab Vision Corporation is recalling five units of Estrogen Receptor AB-11 (Clone ID5) Mouse Monoclonal Antibody. The product is an analytical reagent intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin embedded tissue sections.
The recall was initiated due to reports that the product is not performing as expected. In-house testing conducted by the manufacturer showed no staining on breast cancer tissues, indicating the reagent may fail to detect the intended target.
The affected product is identified by PN/ MS-354-P0, LN 354P1206K, with an expiration date of 03/2015. Distribution was worldwide, including the United States (nationwide, specifically noting TX and MA) and Turkey. Users should stop using the product and contact the manufacturer for instructions.
The recalled product
- 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
- Manufacturer
- Lab Vision Corporation
- Hazard
- Affected units
- 5
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- PN/ MS-354-P0
- LN 354P1206K
- Expiration 03/2015.
Distribution
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