Recall Z-0297-2009
Abbott Diagnostic International, Ltd. · initiated May 22, 2008
Product
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.
Codes / lots: Lot 61275Q100, exp. date: 09/09/08; Lot 58167Q100, exp. date: 08/30/08; Lot 56039Q101, exp. date: 07/13/08; and Lot 56039Q100, exp. date: 07/13/08.
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.
FDA-determined cause: Software change control
Action taken
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.
Details
- Recall number
- Z-0297-2009
- Initiated
- May 22, 2008
- Posted by FDA
- November 21, 2008
- Terminated
- September 9, 2011
- Product code
- KXT – Enzyme Immunoassay, Digoxin
- Quantity
- 9069 kits
- Distribution
- 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…
- Recalling firm
- Abbott Diagnostic International, Ltd., Barceloneta, PR