The Leica ASP6025 Tissue Processor. Pathology and Hematology Departments. The Leica ASP6025 Tissue Processor is an autom

FDA device recall Z-2804-2015 · posted 2015-09-22 · Terminated

Recall details

Recalling firm

Leica Microsystems, Inc.

Reason for recall

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.

Action taken

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 organisation where the potentially affected devices have been transferred. The customer is asked to sign the Medical Device Recall Notification Response Form to confirm that they have received and understand the Medical Device Recall Notification. The customer is requested to confirm receipt of the notice by signing and dating the Acknowledgement Form and faxing it back to Leica at 1-847-236-3747, or scan and email it to LMGRA@leicamicrosystems. com

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

IEO

Quantity affected

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. Foreig

Date initiated

2015-07-27

Date posted

2015-09-22

Date terminated

2017-01-05

Location

Buffalo Grove, IL