Leica Monoclonal Antibody Recalled for Reduced Functionality
Leica Microsystems is recalling Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi because it does not function as intended up to the expiry date.
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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a functional defect (reduced staining intensity) rather than a direct safety risk like contamination or injury, fitting the criteria for a moderate severity score.
Plain-English summary
Leica Microsystems, Inc. is recalling 33 units of Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (Product Code: NCL-L-GSTpi-438). The product is a liquid tissue culture supernatant intended for in vitro diagnostic use. The recall covers specific lot numbers: 6018777, 6023260, 6026297, and 6026980.
The recall was initiated because the product does not function as intended up to the expiry date on the product labeling. This issue was detected through an ongoing stability program, which identified a linkage between the age of the product and staining intensity.
The affected units were distributed nationwide, including in Arizona, California, Florida, and New York. Users of this product should stop using the affected lots and contact Leica Microsystems for further instructions.
The recalled product
- Product
- Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (NCL-L-GSTpi-438), a liquid tissue culture supernatant. For in vitro diagnostic use.
- Manufacturer
- Leica Microsystems, Inc.
- Hazard
- Affected units
- 33
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 (9)
- Product Code: NCL-L-GSTpi-438
- Lot Numbers and Expiration Dates: 6018777
- Expires 2014-05
- 6023260
- Expires 2014-12
- 6026297
- Expires 2015-05
- 6026980
- Expires 2015-06
Distribution
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