TOSOH brand AIA-600 II Enzyme Immunoassay Analyzer; Software version 3.12, Catalog Numbers 019359, 019400; Model 019400, Smart Media
This recall has been terminated (originally issued November 30, 2004).
- Company
- Tosoh Bioscience, Inc.
- Recall Initiated
- April 2, 2003
- Posted
- November 30, 2004
- Terminated
- June 15, 2005
- Recall Number
- Z-0218-05
- Quantity
- 81 units
- Firm Location
- South San Francisco, CA
- Official Source
- View on FDA website ↗
Reason for Recall
A software upgrade was released by the firm for its AIA-600 II analyzers, in that washing deficiencies caused by the analyzer were corrected.
Distribution
81 customers received the upgrade, including customers who received instruments with the upgrade installed already. 37 customers received the v.3.12 installation. In addition, TOSOH bioscience has identified 3 foreign and 5 US customers who required the upgrade. The firm had distributed to 3 US Government medical centers as well. These upgrades have been completed.
Lot / Code Info
All units of these models.
Root Cause
Other
Action Taken
The firm initiated the correction on 4/2/03 via telephone calls and PR on 11/24/04 to all its direct customers, however, the firm indicated that software upgrade was accomplished by the firm's Field Service Engineers.