Leica Novocastr Antibody Recalled for Stability Issues
Leica Microsystems is recalling 270 units of Novocastr Liquid Mouse Monoclonal Antibody RCC because testing showed the product is not stable up to its labeled expiry date.
What this means for you
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 source text does not report any illnesses, injuries, or hospitalizations. The hazard is a stability issue affecting product performance rather than a direct physical injury risk, fitting the criteria for a moderate severity score.
Plain-English summary
Leica Microsystems, Inc. is recalling 270 units of Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC). The affected products are 1ml vials with lot numbers 6036120, 6032345, and 6023543. This antibody is recommended for use as part of a panel to define tumors of proximal nephrogenic differentiation.
The recall was initiated because testing of retained units indicated that the product is not stable up to the expiry date listed on the product labeling. This stability issue affects the reliability of the test results.
The affected units were distributed in the states of Arkansas, California, Connecticut, Florida, Idaho, Illinois, Indiana, Montana, Ohio, Pennsylvania, Tennessee, and Texas, as well as in Canada. Users should stop using the affected lots and contact Leica Microsystems for further instructions.
The recalled product
- Product
- Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) is recommended for use as part of a panel of antibodies in the definition of tumors of proximal nephrogenic differentiation.
- Manufacturer
- Leica Microsystems, Inc.
- Hazard
- Affected units
- 270
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 (1)
- 6032345 and 6023543.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Leica Microsystems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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