Class 3 Device Recall

• Date Initiated by Firm: March 09, 2004
• Date Posted: October 01, 2005
• Recall Status: Terminated on July 22, 2006
• Recall Number: Z-1576-05
• Recall Event ID: 32608
• Product Classification: Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus - Product Code MZO
• Product: ELx800 microtiter plate reader software program written for use with ORTHO HCV Version 3.0 ELISA Test System.
• Code Information: version 12 and older software
• Recalling Firm/ Manufacturer: Diasorin Inc.; 1951 Northwestern Ave S; Stillwater MN 55082-7536
• For Additional Information Contact: DiaSorin Technical Service; 800-328-1482
• Manufacturer Reason for Recall: An error in the acceptance specification for the substrate blank optical density was discovered in the Bio-Tek ELx800 programming specifications for the ORTHO HCV Version 3.0 ELISA Test System Assay.
• FDA Determined Cause: Other
• Action: Dear Customer letters, dated 03/08/2004 were sent to customers informing them of the specification error and instructing users to validate their assays manually.
• Quantity in Commerce: 128
• Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OR, PA, TN, TX, UT, VA, WI & WV
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.