Leica Microsystems, Inc.: Medical Device Recall in 2015 - (Recall #: Z-2804-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: July 27, 2015

Date Posted: September 30, 2015

Recall Number: Z-2804-2015

Event ID: 71928

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.

Status: Terminated

Product Quantity: U.S. Quantity Distributed: 163 systems; Foreign Quantity Diistributed: 410 systems.

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.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated