FDA recall Z-2660-2017

Leica Microsystems, Inc. · Class II · device

Product

Nussloch GmbH ASP6025 Tissue Processor

Reason for recall

Incorrect labeling for specified voltage for the Alarm Connectors on the rear side of the unit.

Distribution

Domestic: AR, AZ, CA, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MO, MT, NC, NE, NJ, NM, NV, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI, WV, & DC. Foreign: Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, England, France, Georgia, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lithuania, Malaysia, Maldives, Mexico, Morocco, Myanmar, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, & United Arab Emirates.

Key facts

Status
Ongoing
Initiation date
2017-06-19
Report date
2017-07-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Buffalo Grove, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2660-2017