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U.S. Department of Health and Human Services

Class 2 Device Recall LIAISON Analyzer

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  Class 2 Device Recall LIAISON Analyzer see related information
Date Initiated by Firm December 05, 2008
Date Posted March 30, 2009
Recall Status1 Terminated 3 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 2
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 and Original Applicant = DIASORIN, INC.
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