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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0; List Number: 3D54-08; Abbott La boratories, Diagnostics Division, Abbott Park, IL 60064
Brand
Abbott Laboratories
Lot Codes / Batch Numbers
Lot Numbers: 59311P100 and 59312P100.
Products Sold
Lot Numbers: 59311P100 and 59312P100.
Abbott Laboratories is recalling AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0; List Number: 3D54-08; Abbott La boratories, due to Error Message: If the Positive and Negative Interpretation Cutoff parameters (116/117) are edited after installation of the revised assay file, VRTX e. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
PR
Page updated: Jan 10, 2026