Leica Microsystems Recalls Unstable CDX2 Antibody Lots
Leica Microsystems is recalling specific lots of Novocastr CDX2 antibody because testing showed they are not stable until their expiration dates.
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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is limited to product instability affecting test reliability, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Leica Microsystems, Inc. is recalling specific lots of Novocastr Liquid Mouse Monoclonal Antibody CDX2. The recall involves 1ml units with lot numbers 6032734, 6033766, 6037153, and 6039088. These products were distributed in the United States (AR, CA, CT, FL, ID, IL, IN, MT, OH, PA, TN, and TX) and in Canada.
The recall was initiated because testing of retained units indicated that the affected lots are not stable up to the expiry date listed on the product labeling. This product is recommended for the assessment of CDX2 protein in normal and neoplastic tissues.
No specific instructions for consumers or healthcare providers are provided in the source text. Users should verify their lot numbers against the list above and contact the manufacturer or their supplier for further guidance.
The recalled product
- Product
- Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the assessment of CDX2 protein in normal and neoplastic tissues.
- Manufacturer
- Leica Microsystems, Inc.
- Hazard
- Affected units
- 90
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 (2)
- 6033766
- 6037153 and 6039088.
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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