FDA Devices recall · Reported August 7, 2013
Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular tissue processor for the following laboratory applications: fixation, dehydration, infiltration with intermedium, and the paraffin infiltration of histological tissue specimens.
The Instruction for Use 1v9 Ref F and all previous versions specify incorrect dimensions for the Ready To Use (RTU) bottles from other suppliers than Leica. In case of a pressure …
Leica Microsystems, Inc. recalled Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular tissue processor … - a moderate-severity action.
Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular tissue processor … was recalled by Leica Microsystems, Inc. in August 7, 2013. Reason: The Instruction for Use 1v9 Ref F and all previous versions specify incorrect dimensions for the Ready To Use…. Check the official notice for the remedy. Verify recall #Z-1815-2013 with the FDA Devices before acting.
The recall
Leica Microsystems, Inc. issued this moderate-severity FDA Devices recall-The Instruction for Use 1v9 Ref F and all previous versions specify incorrect dimensions for the Ready To Use….
- Moderate
- severity level
- Class II
- classification
- August 7, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1815-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular tissue processor for the following laboratory applications: fixation, dehydration, infiltration with intermedium, and the paraffin infiltration of histological tissue specimens.
Reason for recall
The Instruction for Use 1v9 Ref F and all previous versions specify incorrect dimensions for the Ready To Use (RTU) bottles from other suppliers than Leica. In case of a pressure failure of the device in combination with a bottle with incorrect dimensions, overflow can cause contamination of reagents. Additionally, the current instructions for use does not highlight the importance to check the filling levels of all reagent bottles (RTU and system bottles) prior to every process run. Without this important information, risk of tissue damage or loss is possible. Therefore the missing information will be distributed to all customers by a Field Service Notice.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1815-2013 |
| Date reported | August 7, 2013 |
| Date initiated | November 13, 2012 |
| Recalling firm | Leica Microsystems, Inc. |
| Firm location | Buffalo Grove, IL |
| Affected scope | 128 machines |
| Distribution | Worldwide Distribution - USA (nationwide) and internationally to Australia, Belgium, Brazil, Chile, France, Germany, Ireland, Italy, Japan, Malaysia, Mexico, Netherlands, Philipines, Singapore, South Africa, Spain, Switzerland, Thailand, … |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1815-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026