Leica Microsystems Recalls Unstable CD10 Monoclonal Antibody Diagnostic Reagents
Leica Microsystems is recalling specific lots of Novocastra CD10 antibody reagents because they are not stable up to the 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, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The specific hazard is product instability affecting diagnostic reliability rather than direct physical injury.
Plain-English summary
Leica Microsystems, Inc. is recalling specific lots of Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10) used for immunohistochemistry. The affected products are in vitro diagnostic reagents intended for the qualitative identification of CD10 molecules in paraffin sections by light microscopy.
The recall was initiated because the identified lot numbers are not stable up to the expiry date printed on the product labeling. This instability may affect the reliability of the diagnostic results.
The affected products were distributed worldwide, including in the United States, Australia, Austria, Brazil, Canada, China, and other countries. Users of these specific reagent lots should stop using them and contact Leica Microsystems for instructions on return or replacement.
The recalled product
- Product
- Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10). Immunohistochemistry. in vitro diagnostic. 0.1ml NCL-CD10-270 and 1mL NCL-CD10-270 are intended for the qualitative identification by light microscopy of CD10 molecules in paraffin sections.
- Manufacturer
- Leica Microsystems, Inc.
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)
- CD10-270-CE-S (0.1 ml) 6033086 (U.S. Distribution) expire 06/2016
- 6032390 expires 04/2016
Distribution
Distributed nationwide across the United States.
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