| Class 2 Device Recall ASP 6025 Vacuum Tissue Processor |  |
Date Initiated by Firm | March 30, 2012 |
Date Posted | April 27, 2012 |
Recall Status1 |
Terminated 3 on October 10, 2012 |
Recall Number | Z-1473-2012 |
Recall Event ID |
61535 |
Product Classification |
Processor, tissue, automated - Product Code IEO
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Product | ASP 6025 Vacuum Tissue Processor; an automated modular tissue processor; Leica Biosystems Nussloch GmbH, Heidelberger Str. 17-19, D-69226 Nussloch, Germany; The intended use of this device is as an automated system used to process tissue specimens for examination through fixation, dehydration, and infiltration. |
Code Information |
Model ASP6025, serial numbers 162, 163, 168, 169, 170, 171, 182, 183, 184, 200 through 267 |
Recalling Firm/ Manufacturer |
Leica Microsystems, Inc. 1700 Leider Ln Buffalo Grove IL 60089-6622
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For Additional Information Contact | Ms. M. Elizabeth Culotta 847-405-6565 |
Manufacturer Reason for Recall | There is a potential malfunction with the device in autorotation mode, which can lead to incorrect reagent handling of the device. The end result may lead to damage or to loss of tissue specimens. |
FDA Determined Cause 2 | Software design |
Action | Leica Microsystems sent a Urgent Medical device Recall letter dated March 30, 2012, to all affected customers in the U.S. on the same date. The letter identified the product the problem and the action needed to be taken by the customer.
The customer was instructed of the potential malfunction of the device in the autorotation mode, which could lead to damage or loss of tissue specimens.
The letter provided instructions on what the customer should do with the recalled product in the interim before the software fix can be installed. They were instructed to follow the steps below:
1. Remove and dispose all reagents including Paraffin and clean all bottles and Paraffin bathes.
2. Conduct a "Smart Clean" (IFU, chapter 6.1.4).
3. In Submenu "System Setup", here at "Program options", respectively "Station sequence", customer shall switch from "Concentration" to "Auto by RMS".
4. Prestored Xylene protocols shall be used instead of autorotation protocols (IFU, chapter 5.6.2 "Time - optimized Xylene infiltration programs"). Here you find the five validated programs which need to be copied to Favorite programs (IFU, chapter 5.5.3).
5. Use the Reagents, bottle set up from "Time optimized Xylene programs" (IFU, chapter 5.6.2., page 134) and implement them into submenu "Reagents" (IFU, chapter 5.2. following pages).
6. In submenu "The RMS system adjusting warning thresholds rules" (IFU, chapter 5.2.2) the validated reagent thresholds need to be implemented into Submenu "Reagents" (IFU, chapter 5.2).
7. Current Reagent management values are visible within Submenu "Reagent Status" (IFU, chapter 5.2.3)
The customers were also informed that their Leica Microsystems representative will them to make the necessary arrangements to complete a software upgrade at no charge.
The customers were also requested to sign and date the enclosed acknowledgement form and fax it back to Leica at 847-236-3747 or e-mail it to LMGRA@leica-microsystems.com within 10 working da |
Quantity in Commerce | 27 units - U.S., 40 units - ROW |
Distribution | Worldwide Distribution -- USA (nationwide)
including states of: California, Florida, Georgia, Kentucky, Massachusetts, Minnesota, Mississippi, Nebraska, New York, North Carolina, the District of Columbia; and countries of: Australia, Belgium, France, Germany, China/Hong Kong, Italy, Japan, the Netherlands, Singapore, Switzerland, Turkey and United Kingdom. |
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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