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LEICA ASP6025 TISSUE PROCESSOR(2015-08-11)
- Starting date:
- August 11, 2015
- Posting date:
- August 24, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-54782
Affected Products
A. LEICA ASP6025 TISSUE PROCESSOR
Reason
One complaint was received from a customer in Spain where poor processing was identified and samples were deemed non-diagnosable. the investigation of the unit when returned to the manufacturer on July 15th led to a safety meeting which determined that the instrument is incorrectly getting into a state of "bottle empty" during retort filling, after passing the fill lever sensor 2 and prior to reaching level sensor 3, thus not completing a 5 litre fill.
Affected products
A. LEICA ASP6025 TISSUE PROCESSOR
Lot or serial number
314
316
446
448
538
594
622
Model or catalog number
ASP6025
Companies
- Manufacturer
-
Leica Microsystems Nussloch GMBH
HEIDELBERGER STREET 17-19
Nussloch
69222
GERMANY