Class 2 Device Recall LIAISON Analyzer

• Date Initiated by Firm: December 05, 2008
• Date Posted: March 30, 2009
• Recall Status: Terminated on May 22, 2012
• Recall Number: Z-1042-2009
• Recall Event ID: 50704
• 510(K)Number: K032844
• Product Classification: Colorimeter, Photometer, Spectrophotometer for clinical use - Product Code JJQ
• Product: Diasorin LIAISON (R) Chemiluminescence Analyzer Model # 15970. Colorimeter, Photometer, Spectrophotometer for clinical use.
• Code Information: Serial numbers: 2229000828, 2229000829, 2229000839, 2229000857, 2229000859, 2229000926, 2229000972, 2229001196, and 2229001230.
• Recalling Firm/ Manufacturer: Diasorin Inc.; 1951 Northwestern Ave S; Stillwater MN 55082-7536
• For Additional Information Contact: 651-439-9710
• Manufacturer Reason for Recall: DiaSorin determined that there was a potential for a short to occur in a a residual starter pump electrical cable in the LIAISON (R) Analyzer.
• FDA Determined Cause: Device Design
• Action: DiaSorin Inc authorized Field Service Engineer has visited the sites and performed the necessary field correction. Upon completion of their work, the field service engineer generated a Field Service Report and a copy was left with the customer.
• Quantity in Commerce: 9
• Distribution: Worldwide Distribution -- USA including states of NC, NJ, PA, CA, WA, MO, UT, and OR and country of 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 = JJQ