Leica ASP6025 Tissue Processor Recalled for Incomplete Bottle Filling
Leica Microsystems is recalling ASP6025 Tissue Processors because they may incorrectly detect empty bottles during filling, preventing the completion of a 5-liter fill.
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 defect is a functional error (incomplete filling) that does not present an immediate risk of serious injury or death, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Leica Microsystems, Inc. is recalling the Leica ASP6025 Tissue Processor, an automated system used in pathology and hematology departments to process tissue specimens. The recall involves 163 systems distributed in the United States and 410 systems distributed internationally.
The recall is being conducted because the instrument may incorrectly enter a 'bottle empty' state during the retort filling process. This error occurs after the fill lever passes sensor 2 and before reaching level sensor 3, which prevents the machine from completing a 5-liter fill. The affected serial numbers range from 163 to 811, with specific exclusions noted in the official record.
The affected units were distributed to pathology and hematology departments in various U.S. states and numerous foreign countries. Users of these devices should contact Leica Microsystems for further instructions regarding the recall and potential corrective actions.
The recalled product
- Product
- The Leica ASP6025 Tissue Processor. Pathology and Hematology Departments. The Leica ASP6025 Tissue Processor is an automated system used to process tissue specimens for examination through fixation, dehydration and infiltration.
- 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 (20)
- Product Code: Leica ASP6025 Serial Numbers: 163
- 169
- 200-729
- 731
- 733
- 735
- 737
- 739
- 741
- 743
- 745
- 747
- 749
- 751
- 753
- 755
- 757
- 759
- 761
- 763
Distribution
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