Class 3 Device Recall Leica Microsystems Inc.

• Date Initiated by Firm: August 05, 2015
• Date Posted: September 17, 2015
• Recall Status: Terminated on January 05, 2017
• Recall Number: Z-2779-2015
• Recall Event ID: 71910
• Product Classification: Processor, tissue, automated - Product Code IEO
• Product: The Leica ASP200S/ASP300S Tissue Processor. Pathology and Hematology Departments. The Leica ASP200S/ASP300S Tissue Processor is an automated system used to process tissue specimens for examination through fixation, dehydration and infiltration.
• Code Information: Product Code: Leica ASP200S/ASP300S with Serial Numbers: 5682; 5886; 5264; 5267; 5356; 5259; 5956; 5946; 5794; 5385; 5929; 5301; 5401; 5310; 5530; 5909; 5804; 5272; 5724; 5796; 5807; 5446; 5435; 5670; 5947; 5348; 5434; 5388; 5366; 6000; 6131; 5407; 6040; 5799; 5815; 5737; 5706; 5381; 5416; 5673; 5875; 5962; 6041; 6042; 5266; 5948; 5693; 6021; 5610; 5798; 5926; 5387; 5349; 5273; 6115; 5612; 5965; 5955; 5260; 5725; 5871; 5873; 5874; 5562; 6046; 5386; 5977 ;5889; 5398; 6062; 5609; 6015; 5734; 5403; 5289; 5426; 6149; 5663; 6045
• Recalling Firm/ Manufacturer: Leica Microsystems, Inc.; 1700 Leider Ln; Buffalo Grove IL 60089-6622
• For Additional Information Contact: Katya Magee; 847-236-3747
• Manufacturer Reason for Recall: The Leica ASP200S/ASP300S Tissue Processor have an incorrect internal wiring to the remote alarm plug, which can cause the remote alarm to not function correctly in the case of an instrument failure.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Leica Biosystems sent an Urgent Medical Device Recall Notification letter dated August 4, 2015, to all affected customers to provide instructions on what the customer should do with the recalled product. These include 1) As an immediate countermeasure, the firm recommends that the customers do not use the remote alarm function on the Leica ASP200S/ASP300S in its current state. 2) The customers local Leica representative will contact them to arrange for a Leica service engineer to visit their facility to correct the internal wiring on their tissue processor and to check the remote alarm function. 3) The Medical Device Recall Notification needs to be passed on to all those who need to be aware within the custromers organisation or to any organisation where the potentially affected devices have been transferred. Please maintain awareness of this Medical Device Recall Notification and resulting action to ensure effectiveness of the corrective action. 4) The letter asks the customer use the enclosed Medical Device Recall Notification Response Form to confirm that they have received and understand the Medical Device Recall Notification. it states "Please confirm receipt of this notice by signing and dating the attached Acknowledgement Form and faxing it back to us at 1-847-236-3747, or scan and email it to LMGRA@leica-microsystems.com"
• Quantity in Commerce: 901
• Distribution: Worldwide Distribution - US including U.S. including AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MN, MO, MT, NC, NJ, NM, NY, OH, OR, PA, TX, VA, WA, WI, WV and District of Columbia. Internationall to AE, AT, AU , BD , BE, BF, BG,BR, CA, CL, CN, CO, CR, DE, DK, EC, EG, ES, ET, FI, FR, GB, HU, ID, IN, IT, JM, JP, KR, LK, MA, MT, MY, NL, NZ, PA, PE, PH, PL, PT, RO, RU, SA, SE, SG, TH, TR, TW, VN and ZA.
• 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.