Z-2804-2015Class II

The Leica ASP6025 Tissue Processor. Pathology and Hematology Departments. The Leica ASP6025 Tissue Processor...

Name: Z-2804-2015 The Leica ASP6025 Tissue Processor. Pathology and Hematology Departments. The Leica ASP6025 Tissue Processor...
Creator: Leica Microsystems, Inc.
Published: 2015-07-27
License: https://open.fda.gov/license/

Leica Microsystems, Inc. / initiated 2015-07-27 / Terminated / root cause: manufacturing process

FDA source

Leica Microsystems, Inc. began a recall of The Leica ASP6025 Tissue Processor. Pathology and Hematology Departments. The Leica ASP6025 Tissue Processor is an automated system used to process tissue... on 2015-07-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2804-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-27
Posted: 2015-09-22
Terminated: 2017-01-05
Recalling firm: Leica Microsystems, Inc.
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.
Product code: IEO Processor, Tissue, Automated
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.
Root cause tag: manufacturing process
FDA root 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2804-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2804-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-30	2015-09-22

Product code IEO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)