Recall Z-1473-2012 ยท IEO Processor, Tissue, Automated
Leica Microsystems, Inc.
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.
| Date | Apr 27, 2012 (initiated Mar 30, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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. Re |
| Quantity | 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 Nethe |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.