Z-1815-2013Class II

Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular tissue processor for the following...

Name: Z-1815-2013 Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular tissue processor for the following...
Creator: Leica Microsystems, Inc.
Published: 2012-11-13
License: https://open.fda.gov/license/

Leica Microsystems, Inc. / initiated 2012-11-13 / Terminated / root cause: design

FDA source

Leica Microsystems, Inc. began a recall of Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular tissue processor for the following laboratory applications: fixation, dehydration... on 2012-11-13. FDA classified it as Class II and gives the reason as "The Instruction for Use 1v9 Ref F and all previous versions specify incorrect dimensions for the Ready To Use (RTU) bottles from other suppliers than Leica. In case of a pressure failure of the device in combination...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1815-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-13
Posted: 2013-07-29
Terminated: 2017-01-05
Recalling firm: Leica Microsystems, Inc.
Product: Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular tissue processor for the following laboratory applications: fixation, dehydration, infiltration with intermedium, and the paraffin infiltration of histological tissue specimens.
Product code: IEO Processor, Tissue, Automated
Reason for recall: The Instruction for Use 1v9 Ref F and all previous versions specify incorrect dimensions for the Ready To Use (RTU) bottles from other suppliers than Leica. In case of a pressure failure of the device in combination with a bottle with incorrect dimensions, overflow can cause contamination of reagents. Additionally, the current instructions for use does not highlight the importance to check the filling levels of all reagent bottles (RTU and system bottles) prior to every process run. Without this important information, risk of tissue damage or loss is possible. Therefore the missing information will be distributed to all customers by a Field Service Notice.
Root cause tag: design
FDA root cause: Device Design
Action: Leica Biosystems sent an Urgent Field Safety Notice dated December 12, 2012, to all affected customers. The notification included a description of the problem and a recommendation that the personnel who use the equipment only use Leica Ready To Use (RTU) bottles that are already supplied as a standard delivery item with the ASP6025 machine. The personnel are further reminded that reagent bottle levels need to be checked and corrected when necessary. Customers with questions or questions regarding this recall call 847-405-5413.
Quantity in commerce: 128 machines
Distribution: Worldwide Distribution - USA (nationwide) and internationally to Australia, Belgium, Brazil, Chile, France, Germany, Ireland, Italy, Japan, Malaysia, Mexico, Netherlands, Philipines, Singapore, South Africa, Spain, Switzerland, Thailand, Turkey, and United Kingdom.
Product codes and lots: 1) Model ASP6025 120V/50-60 Hz; Serial Numbers: 171, 200, 202, 204, 206, 208, 210, 212, 214, 216, 218, 220, 222, 224, 226, 228, 230, 232, 234, 236, 238, 240, 242, 244, 246, 248, 250, 252, 254, 256, 258, 260, 262, 264, 266, 268, 270, 272, 274, 276, 278, 280, 282, 284, 286, 288, 290, 292, 294; 2) Model ASP6025 230V/50-60 Hz; Serial Numbers: 162, 163, 168, 169, 170, 183, 184, 201, 203, 205, 207, 209, 211, 213, 215, 217, 219, 221, 223, 225, 227, 229, 231, 233, 235, 237, 239, 241, 243, 245, 247, 249, 251, 253, 255, 257, 259, 261, 263, 265, 267, 269, 271, 273, 275, 277, 279, 281, 283, 285, 287, 289, 291, 293, 295, 297, 299, 301, 303, 305, 307, 309, 311, 313, 315, 317, 319, 320, 321, 323, 325, 327, 328, 329, 331, 333, 335, 337, 339

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1815-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1815-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-07	2013-07-29

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)