—#68116

Product

AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0; List Number: 3D54-08; Abbott La boratories, Diagnostics Division, Abbott Park, IL 60064

FDA product code: DKZ — Enzyme Immunoassay, Amphetamine
Device class: Class 2
Medical specialty: Clinical Toxicology
510(k) numbers: K953115
Affected lot / code info: Lot Numbers: 59311P100 and 59312P100.

Why it was recalled

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 (FDA determination)

Software change control

Action the firm took

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.

Recalling firm

Firm: Abbott Laboratories
Address: 100 Abbott Park Rd, Abbott Park, Illinois 60064-3502

Distribution

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.

Timeline

Recall initiated: 2008-01-21
Posted by FDA: 2008-05-14
Terminated: 2009-12-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #68116. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.