ARCHTECT System RS-232 Manual, product list number 06F71-04, for the ARCHITECT i2000 Processing Module and the ARCHITECT
FDA device recall Z-0818-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories, Inc
- Reason for recall
- When using a LIS the software system will send up a test result of up to 20 characters although the field is set to display only 15 characters per the RS-232 Manual.
- Action taken
- Customers were notified by letter on March 23, 2004 to contact their LIS vendor and to reconfigure the ASTM Field 10.1.4 to allow a maximum character length of 20 characters.
- Root cause
- Other
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 101
- Distribution
- Nationwide and to the following foreign countries: Chile, Canada, Germany, Taiwan, Australia, Signapore
- Date initiated
- 2004-03-19
- Date posted
- 2004-07-20
- Date terminated
- 2005-11-03
- Location
- Irving, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABBOTT ARCHITECT TESTOSTERONE (K983212) | Abbott Laboratories | 1998-11-18 |
| AEROSET SYSTEM (K980367) | Abbott Laboratories | 1998-04-01 |