Leica ASP6025 Vacuum Tissue Processor Recalled for Incorrect Bottle Dimensions
Leica Microsystems is recalling 128 ASP6025 tissue processors because the manual lists incorrect dimensions for third-party bottles, risking reagent contamination and tissue loss.
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 hazard is limited to a labeling error that creates a theoretical risk of reagent contamination and tissue loss, with no reported injuries or illnesses.
Plain-English summary
Leica Microsystems, Inc. is recalling 128 Leica ASP6025 Vacuum Tissue Processors. These devices are used in laboratories for the fixation, dehydration, and paraffin infiltration of histological tissue specimens. The recall covers units distributed nationwide in the United States and internationally to 20 other countries.
The recall is due to an error in the Instruction for Use (Ref F and previous versions), which specifies incorrect dimensions for Ready To Use (RTU) bottles from suppliers other than Leica. If the device experiences a pressure failure while using a bottle with incorrect dimensions, overflow can occur, leading to the contamination of reagents. Additionally, the current instructions fail to emphasize the importance of checking the filling levels of all reagent bottles prior to every process run. Without this information, there is a risk of tissue damage or loss.
Leica Microsystems is distributing the missing information to all customers via a Field Service Notice to address the labeling error and provide necessary operational guidance.
The recalled product
- Product
- 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.
- Manufacturer
- Leica Microsystems, Inc.
- Affected units
- 128
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)
- 1) Model ASP6025 120V/50-60 Hz
- Serial Numbers: 171
- 200
- 202
- 204
- 206
- 208
- 210
- 212
- 214
- 216
- 218
- 220
- 222
- 224
- 226
- 228
- 230
- 232
- 234
Distribution
Distributed nationwide across the United States.
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