The Leica ASP200S/ASP300S Tissue Processor. Pathology and Hematology Departments. The Leica ASP200S/ASP300S Tissue Proce

FDA device recall Z-2779-2015 · posted 2015-09-17 · Terminated

Recall details

Recalling firm

Leica Microsystems, Inc.

Reason for recall

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.

Action taken

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 function. 3) The Medical Device Recall Notification needs to be passed on to all those who need to be aware within the custromers organisation or to any organisation where the potentially affected devices have been transferred. Please maintain awareness of this Medical Device Recall Notification and resulting action to ensure effectiveness of the corrective action. 4) The letter asks the customer use the enclosed Medical Device Recall Notification Response Form to confirm that they have received and understand the Medical Device Recall Notification. it states "Please confirm receipt of this notice by signing and dating the attached Acknowledgement Form and faxing it back to us at 1-847-236-3747, or scan and email it to LMGRA@leica-microsystems.com"

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

IEO

Quantity affected

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. In

Date initiated

2015-08-05

Date posted

2015-09-17

Date terminated

2017-01-05

Location

Buffalo Grove, IL