TOSOH brand AIA-600 II Enzyme Immunoassay Analyzer; Software version 3.12, Catalog Numbers 019359, 019400; Model 019400,
FDA device recall Z-0218-05 · posted 2004-11-30 · Terminated
Recall details
- Recalling firm
- Tosoh Bioscience, Inc.
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- NIG
- Quantity affected
- 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 ide
- Date initiated
- 2003-04-02
- Date posted
- 2004-11-30
- Date terminated
- 2005-06-15
- Location
- South San Francisco, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM (K971103) | Tosoh Medics, Inc. | 1997-06-27 |