AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0; List Number: 3D54-08; Abbott La boratories, Diagnostics Division
FDA device recall Z-1462-2008 · posted 2008-05-14 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories
- Reason for recall
- Error Message: If the Positive and Negative Interpretation Cutoff parameters (116/117) are edited after installation of the revised assay file, VRTX error #0002 in Task 40 is generated and the instrument locks up when it attempts to report an AxSYM Amphetamine/Methamphetamine II patient result.
- Action taken
- Consignees were sent a Product Correction-Immediate Action Required letter on 1/21/08. The letter provided users with the steps to take to temporarily correct the problem until the recalling firm is able to send a corrected assay file. 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
- DKZ
- Quantity affected
- 1,270 disks
- Distribution
- Worldwide Distribution including USA territory of Puerto Rico, and countries of Australia, Canada, Chile, Colombia, Germany, Mexico, New Zealand, South Korea, Taiwan, Thailand and Venezuela.
- Date initiated
- 2008-01-21
- Date posted
- 2008-05-14
- Date terminated
- 2009-12-01
- Location
- Abbott Park, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AXSYM AMPHETAMINE/METHAMPHETAMINE II (K953115) | Abbott Laboratories | 1995-10-06 |