Z-2325-2009

ARCHITECT i System Assay CD ROM - US, list 6E58-22, Version 22.01, and ARCHITECT i System Assay CD-ROM - WW...

Name: Z-2325-2009 ARCHITECT i System Assay CD ROM - US, list 6E58-22, Version 22.01, and ARCHITECT i System Assay CD-ROM - WW...
Creator: Abbott Laboratories
Published: 2009-04-24
License: https://open.fda.gov/license/

Abbott Medical / initiated 2009-04-24 / Terminated / root cause: software

FDA source

Abbott Laboratories began a recall of ARCHITECT i System Assay CD ROM - US, list 6E58-22, Version 22.01, and ARCHITECT i System Assay CD-ROM - WW (excluding US), list 6E59-23, Version 23.0... on 2009-04-24. The reason FDA records is "There continues to be an elevated level of complaint activity for calibration error code 1227, when using ARCHITECT LH reagent lots (6C25-22 or 6C25-27) due to the use of assay disk versions that do not contain the...". 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-2325-2009
Status: Terminated
Initiated: 2009-04-24
Posted: 2009-09-30
Terminated: 2009-11-30
Recalling firm: Abbott Medical
Product: ARCHITECT i System Assay CD ROM - US, list 6E58-22, Version 22.01, and ARCHITECT i System Assay CD-ROM - WW (excluding US), list 6E59-23, Version 23.0, containing the ARCHITECT LH assay file; Abbott Laboratories, Diagnostic Division, Abbott Park, IL 60064 USA; Product List Number: 6E58 (US) and 6E59 (WW) Versions 23 and lower. The Architect LH assay is a Chemiluminescent Microparticle Immunoassay for the quantitative determination of human luteinizing hormone (LH) in human serum or plasma.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: There continues to be an elevated level of complaint activity for calibration error code 1227, when using ARCHITECT LH reagent lots (6C25-22 or 6C25-27) due to the use of assay disk versions that do not contain the updated ARCHITECT LH assay file contained on ARCHITECT i System Assay CD ROM versions 24 and higher (US LN 6E58, WW LN 6E59).
Root cause tag: software
FDA root cause: Software change control
Action: Abbott issued a "Product Correction-Immediate Action Required" letter dated April 24, 2009. The letter provided users with the steps to take to determine what version of the ARCHITECT LH Assay is on their instrument and instructions for installing the assay file provided with the letter if needed. Users were requested to return a customer reply letter acknowledging receipt of the letter. For additional information, contact 1-877-4ABBOTT.
Quantity in commerce: 1,037CD-ROMs - US, 4,676 CD-ROMs - WW
Distribution: Worldwide Distribution -- United States including Puerto Rico and Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Curacao, Germany, Guatemala, Hong Kong, Japan, Mexico, New Zealand, Peru, Singapore, South Korea, Taiwan, Thailand, Uruguay and Venezuela.
Product codes and lots: Product List Number: 6E58 (US) Version 22.01and 6E59 (WW) Version 23.0 and lower, all serial numbers.

Product code JJE

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)