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U.S. Department of Health and Human Services

Class 2 Device Recall LIAISON Analyzer

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 Class 2 Recall
LIAISON Analyzer
see related information
Date Posted March 30, 2009
Recall Status1 Open
Recall Number Z-1042-2009
Recall Event ID 50704
Premarket Notification
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, Minnesota 55082-7536
Consumer Instructions Contact the recalling firm for information
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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JJQ and Original Applicant = DIASORIN, INC.
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