Recall Z-1462-2008 ยท DKZ Enzyme Immunoassay, Amphetamine
Abbott Laboratories
AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0; List Number: 3D54-08; Abbott La boratories, Diagnostics Division, Abbott Park, IL 60064
| Date | May 14, 2008 (initiated Jan 21, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software change control |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K953115 | AXSYM AMPHETAMINE/METHAMPHETAMINE II Abbott Laboratories, Oct 6, 1995 |