FDA Medical Device Recalls (openFDA)
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 number
- Z-0818-04
- Recalling firm
- Abbott Laboratories, Inc
- 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
- Status
- Terminated
- Initiated
- 2004-03-19
- Posted
- 2004-07-20
- Terminated
- 2005-11-03
- 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
- Lot, serial or model codes
- The RS-232 Manual is not controlled by control or lot numbers.
- 510(k) numbers
- ["K980367","K983212"]
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 1628664
- Firm city
- Irving
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28