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Terminated

AxSYM Digoxin II Reagent Pack, Disk Version 1. (3D53-01 or 3D53-02) The AxSYM Digoxin II assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative measurement of digoxin, a cardiovascular drug, in serum or plasma. The measurements obtained are used in the treatment of digoxin overdose and monitoring levels of digoxin to ensure appropriate therapy.

FDA Recall Z-0297-2009 · Posted 2008-11-21

Recalling FirmAbbott Diagnostic International, Ltd.
Recall StatusTerminated
Product CodeKXT
Date Initiated2008-05-22
Date Terminated2011-09-09
Product Quantity9069 kits

Reason for Recall

AxSYM TDM/ Transplant Assay Disks 3D53-03 and higher do not contain the AxSYM Digoxin II Assay file. The instrument might require installation of the AxSYM Digoxin II assay file.

Firm Action

A Product Information letter, dated May 22, 2008, was issued to customers. It requested that one of the following two actions be taken if the AxSYM Digoxin II assay file is not installed on your AxSYM instrument and you want to run the AxSYM Digoxin II assay. If you have one of the previously manufactured software disks listed, [AxSYM Digoxin II Assay Disk, LN 2C43-01, or higher; or AxSYM TDM/Transplant Assay Disk Version 1.0 (3D53-01) or Version 2.0 (3D53-02)], install the AxSYM Digoxin II assay file. Do not install any other assay file. If you do not have one of the assay disks listed, contact your local Customer Service representative to have this assay file installed or install the file from a previous version if you have it on hand.

Root Cause

Software change control

Distribution Pattern

Worldwide Distribution --- USA including states of AL, AZ, AR, CA, CT, FL, GA, IL, KS, MD, MA, MI, MN, MS, MO, NV, NJ, NY, ND, OK, OR, PA, RI, TX, VA, WA, Hawaii, and Puerto Rico, and countries of Canada, Mexico, Guatemala, Costa Rica, Venezuela, Colombia, Ecuador, Peru, Chile, Uruguay, Argentina, Puerto Rico, Germany, Japan, Singapore, Hong Kong, Taiwan, Thailand, South Korea, Australia, New Zealand, Curacao, and Panama.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K953718AXSYM DIGOXIN IIAbbott Laboratories · 1995-09-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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