| | Class 2 Device Recall Leica ASP6025 Advanced Smart Processor Vacuum Tissue Processor |  |
| Date Initiated by Firm | November 13, 2012 |
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| Date Posted | July 29, 2013 |
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| Recall Status1 |
Terminated 3 on January 05, 2017 |
| Recall Number | Z-1815-2013 |
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| Recall Event ID |
63935 |
| Product Classification |
Processor, tissue, automated - Product Code IEO
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| 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. |
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| 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 |
| FEI Number |
3000210133
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Recalling Firm/
Manufacturer |
Leica Microsystems, Inc.
1700 Leider Ln
Buffalo Grove
IL
60089-6622
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| For Additional Information Contact | Ms. Katya Magee
847-405-5413 |
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Manufacturer 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. |
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FDA Determined
Cause 2 | Device Design |
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| 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. |
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| Quantity in Commerce | 128 machines |
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| 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. |
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| Total Product Life Cycle | TPLC Device Report |
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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.
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