Recall Z-0218-05 ยท NIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
Tosoh Bioscience, Inc.
TOSOH brand AIA-600 II Enzyme Immunoassay Analyzer; Software version 3.12, Catalog Numbers 019359, 019400; Model 019400, Smart Media
| Date | Nov 30, 2004 (initiated Apr 2, 2003) |
| Status | Terminated |
| Reason | A software upgrade was released by the firm for its AIA-600 II analyzers, in that washing deficiencies caused by the analyzer were corrected. |
| Root cause | Other |
| Action | 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. |
| Quantity | 81 units |
| 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 Go |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K971103 | AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM Tosoh Medics, Inc., Jun 27, 1997 |