AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0; List Number: 3D54-08; Abbott La boratories, Diagnostics Division, Abbott Park, IL 60064
FDA Recall Z-1462-2008 · Posted 2008-05-14
Advertisement
Recalling FirmAbbott Laboratories
Recall StatusTerminated
Product CodeDKZ
Date Initiated2008-01-21
Date Terminated2009-12-01
Product Quantity1,270 disks
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.
Firm 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.
Root Cause
Software change control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement