Open, Classified

Nussloch GmbH ASP6025 Tissue Processor

FDA Recall Z-2660-2017 · Posted None

Recalling FirmLeica Microsystems, Inc.

Recall StatusOpen, Classified

Product CodeIEO

Date Initiated2017-06-19

Product Quantity812 units

Reason for Recall

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

Firm Action

Customers were notified via email on 06/19/2017. Instructions to customers included to clean surface around the Alarm Connectors and place the newly provided label at the Alarm Connectors (over the engraved specification). They were also instructed to update their current Instructions For Use and update the online help function in the software, as well as return the response form.

Root Cause

Labeling mix-ups

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.