Recall Z-2779-2015 ยท IEO Processor, Tissue, Automated
Leica Microsystems, Inc.
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.
| Date | Sep 17, 2015 (initiated Aug 5, 2015) |
| Status | Terminated |
| Reason | The Leica ASP200S/ASP300S Tissue Processor have an incorrect internal wiring to the remote alarm plug, which can cause the remote alarm to not function correctly in the case of an instrument failure. |
| Root cause | Nonconforming Material/Component |
| Action | Leica Biosystems sent an Urgent Medical Device Recall Notification letter dated August 4, 2015, to all affected customers to provide instructions on what the customer should do with the recalled product. These include 1) As an immediate countermeasure, the firm recommends that the customers do not use the remote alarm function on the Leica ASP200S/ASP300S in its current state. 2) The customers local Leica representative will contact them to arrange for a Leica service engineer to visit their facility to correct the internal wiring on their tissue processor and to check the remote alarm functio |
| Quantity | 901 |
| Distribution | Worldwide Distribution - US including U.S. including AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MN, MO, MT, NC, NJ, NM, NY, OH, OR, PA, TX, VA, WA, WI, WV and District of Columbia. Internationall to AE, AT, AU , BD , BE, BF, BG,BR, CA, CL, CN, CO, CR, DE, DK, EC, EG, ES, ET, FI, FR |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.