Lab Vision Recalls CEA/CD66e Antibody Lots Due to Dilution Error
Lab Vision Corporation is recalling specific lots of CEA/CD66e Ab-2 antibody because they were produced with an incorrect dilution factor.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a manufacturing deviation (dilution factor) rather than a direct safety hazard like contamination or structural failure.
Plain-English summary
Lab Vision Corporation is recalling certain lots of CEA/CD66e Ab-2, a product used for qualitative immunohistochemistry with formalin-fixed, paraffin-embedded tissue sections. The affected product codes are RB-368-R7 and RB-368-R1. The recall involves specific lot numbers (368R1407A, 368R1407C, 368R1407D, 368R1407E, and 368R1407B) with expiry dates of July 2016.
The recall was initiated because the affected lots were produced with a dilution factor of 1:100 instead of the recommended 1:250. This deviation from the recommended dilution factor may affect the performance of the antibody in immunohistochemical testing.
The affected products were distributed worldwide, including in the United States (California, New York, Georgia, Mississippi, Pennsylvania, Massachusetts, Texas, Kentucky, and Arizona) and internationally to Greece, France, Germany, Singapore, and Serbia. Users of these products should stop using the affected lots and contact Lab Vision Corporation for further instructions or a replacement.
The recalled product
- Product
- CEA / CD66e Ab-2, Product code RB-368-R7, RB-368-R1; 7 ml each. Description Carcinoembryonic antigen (CEA), is synthesized during development in the fetal gut, and is re-expressed in increased amounts in intestinal carcinomas and several other tumors. Antibody to CEA is…
- Manufacturer
- Lab Vision Corporation
- Hazard
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 (5)
- Product Code: RB-368-R7
- RB368-R1
- Lot Number 368R1407A 368R1407C 368R1407D 368R1407E
- all with expiry dates of July 2016. Product code: RB368-R1
- Lot Number 368R1407B.
Distribution
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