ARCHITECT c8000 Processing Module; List Number 01G06-01. Manufactured by Toshiba Corporation, Medical Systems Division,
FDA device recall Z-1341-04 · posted 2004-08-13 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories, Inc
- Reason for recall
- Process change in the manufacturing of the AC/DC driver board used on the analyzer may result in one or more of the solid state relays to fail during use.
- Action taken
- The firm initiated the recall by Technical Service Bulletin sent to affected customers. The AC/DC boards will be replaced on each analyzer by a firm representative.
- Root cause
- Other
- Status
- Terminated
- Product code
- CGZ
- Quantity affected
- 171 units and 25 spare parts distributed
- Distribution
- Product was distrbued nationwide and to the following foreign countries: Mexico, Australia, Germany, Hong Kong, Canada, Thailand, Grand Cayman, Chile, New Zealand, Columbia, Brazil, and Singapore.
- Date initiated
- 2004-06-10
- Date posted
- 2004-08-13
- Date terminated
- 2004-11-19
- Location
- Irving, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AEROSET SYSTEM (K980367) | Abbott Laboratories | 1998-04-01 |