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

FDA device recall Z-2325-2009 · posted 2009-09-30 · Terminated

Recall details

Recalling firm

Abbott Laboratories

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).

Action taken

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.

Root cause

Software change control

Status

Terminated

Product code

JJE

Quantity affected

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,

Date initiated

2009-04-24

Date posted

2009-09-30

Date terminated

2009-11-30

Location

Abbott Park, IL