Leica BOND Polymer Refine Detection Kit Recalled for Storage Issues
Leica Microsystems is recalling 558 BOND Polymer Refine Detection Kits because they were stored improperly, which may result in suboptimal staining.
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 suboptimal performance rather than direct physical injury or death, fitting the criteria for a moderate severity recall.
Plain-English summary
Leica Microsystems, Inc. is recalling 558 units of the BOND Polymer Refine Detection Kit, Catalog No. DS9800, Lot 65549. This in vitro diagnostic product is used for staining sections of formalin-fixed, paraffin-embedded tissue on the BOND automated system.
The recall was initiated because the kits were held out of refrigerated storage for longer than specified. This storage deviation may cause the kits to exhibit suboptimal staining performance.
The affected products were distributed nationwide and to Canada. Users of this product should stop using the affected kits and contact Leica Microsystems for further instructions.
The recalled product
- Product
- BOND Polymer Refine Detection Kit, Catalog No. DS9800. This detection system is for in vitro diagnostic use. Bond Polymer Refine Detection is a biotin-free, polymeric horseradish peroxidase (HRP)-linker antibody conjugate system for the detection of tissue-bound mouse and…
- Manufacturer
- Leica Microsystems, Inc.
- Affected units
- 558
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)
- Lot: 65549
Distribution
Distributed nationwide across the United States.
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