Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular tissue processor for the following laboratory appli

FDA device recall Z-1815-2013 · posted 2013-07-29 · Terminated

Recall details

Recalling firm

Leica Microsystems, Inc.

Reason for recall

The Instruction for Use 1v9 Ref F and all previous versions specify incorrect dimensions for the Ready To Use (RTU) bottles from other suppliers than Leica. In case of a pressure failure of the device in combination with a bottle with incorrect dimensions, overflow can cause contamination of reagents. Additionally, the current instructions for use does not highlight the importance to check the filling levels of all reagent bottles (RTU and system bottles) prior to every process run. Without this important information, risk of tissue damage or loss is possible. Therefore the missing information will be distributed to all customers by a Field Service Notice.

Action taken

Leica Biosystems sent an Urgent Field Safety Notice dated December 12, 2012, to all affected customers. The notification included a description of the problem and a recommendation that the personnel who use the equipment only use Leica Ready To Use (RTU) bottles that are already supplied as a standard delivery item with the ASP6025 machine. The personnel are further reminded that reagent bottle levels need to be checked and corrected when necessary. Customers with questions or questions regarding this recall call 847-405-5413.

Root cause

Device Design

Status

Terminated

Product code

IEO

Quantity affected

128 machines

Distribution

Worldwide Distribution - USA (nationwide) and internationally to Australia, Belgium, Brazil, Chile, France, Germany, Ireland, Italy, Japan, Malaysia, Mexico, Netherlands, Philipines, Singapore, South

Date initiated

2012-11-13

Date posted

2013-07-29

Date terminated

2017-01-05

Location

Buffalo Grove, IL