Recall Z-0818-04 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Abbott Laboratories, Inc
ARCHTECT System RS-232 Manual, product list number 06F71-04, for the ARCHITECT i2000 Processing Module and the ARCHITECT c8000 Processing Module. The product is manufactured and distributed by Abbott Laboratories Diagnostic Division, Irving, TX 75038
| Date | Jul 20, 2004 (initiated Mar 19, 2004) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 101 |
| Distribution | Nationwide and to the following foreign countries: Chile, Canada, Germany, Taiwan, Australia, Signapore |
| FDA record | Open on fda.gov |