Leica Calretinin Antibody Recalled for Reduced Staining Performance
Leica Microsystems is recalling Novocastra Calretinin antibodies because they may show reduced staining when used with specific diluent lots.
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. The hazard is a performance defect (reduced staining) rather than a direct physical injury or contamination, fitting the criteria for a moderate severity issue where the risk is primarily to the validity of diagnostic results.
Plain-English summary
Leica Microsystems, Inc. is recalling 290 units of Novocastra Liquid Mouse Monoclonal Antibody Calretinin (NCL-L-CALRET-566). The product is intended for the qualitative identification of the human calretinin molecule in paraffin sections by light microscopy.
The recall was initiated because the antibody, when used in combination with specific lots of antibody diluent, will give reduced staining. This performance issue may affect the reliability of the test results.
The affected units were distributed worldwide, including in the United States (AK, CA, FL, GA, MN, MT, NJ, OH, TX, and WA) and Canada. The specific lot numbers involved are 6025204, 6029060, 6029949, 6035923, and 6036060. Users should stop using these specific lots and contact the manufacturer for instructions.
The recalled product
- Product
- Novocastra Liquid Mouse Monoclonal Antibody Calretinin, NCL-L-CALRET-566. Intended for the qualitative identification by light microscopy of human calretinin molecule in paraffin sections.
- Manufacturer
- Leica Microsystems, Inc.
- Hazard
- Affected units
- 290
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 (4)
- Lot numbers: 6025204
- 6029060
- 6029949
- 6035923 and 6036060.
Distribution
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