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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Abbott Laboratories, Inc
Lot Codes / Batch Numbers
The RS-232 Manual is not controlled by control or lot numbers.
Products Sold
The RS-232 Manual is not controlled by control or lot numbers.
Abbott Laboratories, Inc is recalling ARCHTECT System RS-232 Manual, product list number 06F71-04, for the ARCHITECT i2000 Processing Modu due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026