Class 3 Device Recall DiaSorin programming software

• Date Initiated by Firm: April 20, 2004
• Date Posted: April 06, 2005
• Recall Status: Terminated on July 22, 2006
• Recall Number: Z-0672-05
• Recall Event ID: 30920
• 510(K)Number: K944505
• Product Classification: Extractable Antinuclear Antibody, Antigen And Control - Product Code LLL
• Product: Software written for a specific automated microtiter plate instrument, Bio-Tek ELx800 reader for use with the ENA 6 Screen ELISA kit assay.
• Code Information: software versions 9 thru 12
• Recalling Firm/ Manufacturer: Diasorin Inc.; 1951 Northwestern Ave S; Stillwater MN 55082-7536
• For Additional Information Contact: DiaSorin Technical Services; 800-328-1482
• Manufacturer Reason for Recall: An error in the Bio-Tek ELx800 microplate reader programming specifications for the ENA screen Assay exists in that an equivocal (borderline) zone is missing.
• FDA Determined Cause: Other
• Action: Customers were sent a notification letter informing customers of an error in the Bio-Tek ELx800 programming specifications. Customers were asked to repeat testing for historical runs for RSLT (S/CO) that read from 0.95 to 1.0. A response form is asked to be faxed back to DiaSorin.
• Quantity in Commerce: 29
• Distribution: CT, FL, NY, WA, TX, AR, TN, CANADA
• 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.

• 510(K) Database: 510(K)s with Product Code = LLL