Leica ASP200S/ASP300S Tissue Processor Recall for Wiring Defect
Leica Microsystems is recalling 901 tissue processors due to incorrect internal wiring that may prevent remote alarms from functioning during instrument failure.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classified this as a Class III recall, which is defined as unlikely to cause adverse health consequences. The defect involves a functional alarm failure rather than a direct physical hazard to the user.
Plain-English summary
Leica Microsystems, Inc. is recalling 901 units of the Leica ASP200S/ASP300S Tissue Processor. These automated systems are used in pathology and hematology departments to process tissue specimens for examination through fixation, dehydration, and infiltration.
The recall is due to incorrect internal wiring to the remote alarm plug. This defect can cause the remote alarm to not function correctly in the case of an instrument failure. The affected units were distributed worldwide, including in the United States and numerous international locations.
Users of these devices should contact Leica Microsystems, Inc. for further instructions on how to resolve the wiring issue. The specific serial numbers of the affected units are listed in the agency's recall record.
The recalled product
- Product
- The Leica ASP200S/ASP300S Tissue Processor. Pathology and Hematology Departments. The Leica ASP200S/ASP300S Tissue Processor is an automated system used to process tissue specimens for examination through fixation, dehydration and infiltration.
- Manufacturer
- Leica Microsystems, Inc.
- Affected units
- 901
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 ASP200S/ASP300S with Serial Numbers: 5682
- 5886
- 5264
- 5267
- 5356
- 5259
- 5956
- 5946
- 5794
- 5385
- 5929
- 5301
- 5401
- 5310
- 5530
- 5909
- 5804
- 5272
- 5724
- 5796
Distribution
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