Recall Z-2804-2015 ยท IEO Processor, Tissue, Automated
Leica Microsystems, Inc.
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.
| Date | Sep 22, 2015 (initiated Jul 27, 2015) |
| Status | Terminated |
| Reason | The ASP6025 Tissue Processor 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. |
| Root cause | Nonconforming Material/Component |
| Action | Leica sent an Urgent Medical Device Recall Notification letter dated August 11, 2015, to all affected customers via USPS 1st class mail .. Thel letter advised users to 1) do not use the instrument in 3 basket (5L) mode. Instead it advises the customer to change settings to use only the 2 basket (3.8L) mode only. 2) Prompt acknowledgement is requested by the customer 3) when a permanent solution is found a Leiica representative will contact the customer. 4) The Medical Device Recall Notification needs to be passed on to all those who need to be aware within the customers organisation or to any |
| Quantity | U.S. Quantity Distributed: 163 systems; Foreign Quantity Diistributed: 410 systems. |
| Distribution | Worldwide Distribution - US including AR, AZ, CA, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MN, MO, MT, NC, NE, NJ, NM, NV, NY, OH,PA, SC, TN, TX, VA, WA, WI, WV and District of Columbia. Foreign distribution to United Arab Emirates, Australia, Belgium, Brazil, Canada, Switzerland, Chile, Chin |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.