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

FDA Device Recall #Z-1815-2013 — Class II — November 13, 2012

Recall Summary

Recall Number Z-1815-2013
Classification Class II — Moderate risk
Date Initiated November 13, 2012
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Leica Microsystems, Inc.
Location Buffalo Grove, IL
Product Type Devices
Quantity 128 machines

Product Description

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.

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.

Distribution Pattern

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.

Lot / Code Information

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

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Z-0475-2023 Class II Leica MICROSYSTEMS Proveo 8, Part Number 104490... Nov 21, 2022
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Z-1848-2022 Class II Leica Surgical Operating Microscopes, ARveo 8, ... Aug 26, 2022

Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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