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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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…
- 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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