Class 2 Device Recall Leica Microsystems Inc.

• Date Initiated by Firm: July 27, 2015
• Date Posted: September 22, 2015
• Recall Status: Terminated on January 05, 2017
• Recall Number: Z-2804-2015
• Recall Event ID: 71928
• Product Classification: Processor, tissue, automated - Product Code IEO
• Product: The Leica ASP6025 Tissue Processor. Pathology and Hematology Departments.; ; The Leica ASP6025 Tissue Processor is an automated system used to process tissue specimens for examination through fixation, dehydration and infiltration.
• Code Information: Product Code: Leica ASP6025 Serial Numbers: 163, 169, 200-729, 731, 733, 735, 737, 739, 741, 743, 745, 747, 749, 751, 753, 755, 757, 759, 761, 763, 765, 767, 769, 771, 773, 775, 777, 779, 781, 783, 785, 787, 789, 791, 793, 795, 797, 799, 801, 803, 805, 807, 809, 811.
• Recalling Firm/ Manufacturer: Leica Microsystems, Inc.; 1700 Leider Ln; Buffalo Grove IL 60089-6622
• For Additional Information Contact: Katya Magee; 847-405-5413
• Manufacturer 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.
• FDA Determined Cause: Nonconforming Material/Component
• Action: 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
• Quantity in Commerce: 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. Foreign distribution to United Arab Emirates, Australia, Belgium, Brazil, Canada, Switzerland, Chile, China, Colombia, Czech Republic , Germany, Spain, France, England, Georgia, Indonesia, Ireland, Israel, India, Italy, Jordan, Japan, Korea, Kuwait, Lithuania, Myanmar, Mexico, Malaysia, Netherland, Norway, Peru, Philippines, Poland, Qatar, Reunion, Romania, Serbia, Saudi Arabia, Singapore, Slovenia, Thailand, Turkey, Taiwan, and South Africa.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.