Leica CD15 Antibody Recalled for Decreasing Staining Intensity
Leica Microsystems is recalling 309 units of CD15 antibody because staining intensity decreases over shelf life.
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 decrease in staining intensity which is a functional defect rather than a direct physical or biological injury risk.
Plain-English summary
Leica Microsystems, Inc. is recalling 309 units of Liquid Mouse Monoclonal Antibody CD15 (Product Code: NCL-L-CD15). The product is used in laboratories to perform immunohistochemical (IHC) staining for the qualitative identification of CD15 molecules in paraffin sections.
The recall was initiated because the staining intensity of the antibody decreases over its shelf life. This issue may affect the reliability of the staining results.
The affected lots are 6022274 (Expiry 2015-04), 6024628 (Expiry 2015-08), and 6030581 (Expiry 2016-07). The product was distributed worldwide, including in the United States and numerous international locations. Users should stop using the affected product and contact the manufacturer for further instructions.
The recalled product
- Product
- Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunohistochemical (IHC) staining. Product Usage: NCL-L-CD15 is intended for the qualitative identification by light microscopy of CD15 molecules in paraffin sections. The clinical interpretation of any…
- Manufacturer
- Leica Microsystems, Inc.
- Affected units
- 309
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 (7)
- Product Code: NCL-L-CD15
- Lot Numbers and Expiration Dates: Lot 6022274
- Expiry 2015-04
- Lot 6024628
- Expiry 2015-08
- Lot 6030581
- Expiry 2016-07
Distribution
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