Z-0818-04

ARCHTECT System RS-232 Manual, product list number 06F71-04, for the ARCHITECT i2000 Processing Module and...

Name: Z-0818-04 ARCHTECT System RS-232 Manual, product list number 06F71-04, for the ARCHITECT i2000 Processing Module and...
Creator: Abbott Laboratories, Inc
Published: 2004-03-19
License: https://open.fda.gov/license/

Abbott Medical / initiated 2004-03-19 / Terminated / root cause: software

FDA source

Abbott Laboratories, Inc began a recall of ARCHTECT System RS-232 Manual, product list number 06F71-04, for the ARCHITECT i2000 Processing Module and the ARCHITECT c8000 Processing Module. The product... on 2004-03-19. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0818-04
Status: Terminated
Initiated: 2004-03-19
Posted: 2004-07-20
Terminated: 2005-11-03
Recalling firm: Abbott Medical
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
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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.
Root cause tag: software
FDA 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 in commerce: 101
Distribution: Nationwide and to the following foreign countries: Chile, Canada, Germany, Taiwan, Australia, Signapore
Product codes and lots: The RS-232 Manual is not controlled by control or lot numbers.

Product code JJE

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)