AxSYM Digoxin II Reagent Pack, Disk Version 1. (3D53-01 or 3D53-02) The AxSYM Digoxin II assay is a Microparticle Enzyme
FDA device recall Z-0297-2009 · posted 2008-11-21 · Terminated
Recall details
- Recalling firm
- Abbott Diagnostic International, Ltd.
- 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.
- 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.
- Root cause
- Software change control
- Status
- Terminated
- Product code
- KXT
- Quantity affected
- 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 Can
- Date initiated
- 2008-05-22
- Date posted
- 2008-11-21
- Date terminated
- 2011-09-09
- Location
- Barceloneta, PR
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AXSYM DIGOXIN II (K953718) | Abbott Laboratories | 1995-09-25 |