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U.S. Department of Health and Human Services

Class 2 Device Recall Perkin Elmer

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  Class 2 Device Recall Perkin Elmer see related information
Date Initiated by Firm January 09, 2012
Date Posted February 28, 2012
Recall Status1 Terminated 3 on March 06, 2013
Recall Number Z-1116-2012
Recall Event ID 61031
510(K)Number K090846  
Product Classification Fluorometer, for clinical use - Product Code KHO
Product Perkin Elmer Genetic Screening Processor (GSP) Product code: 2021-0010. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids.
Code Information Serial numbers from 20210012 to 20210021
Recalling Firm/
Manufacturer		 PerkinElmer Life and Analytical Sciences, Wallac, OY
Mustionkatu 6, P.O. Box 10
Turku Finland
Manufacturer Reason
for Recall		 GSP instruments with defective washer modules may cause a false negative screening result being reported for T4, TSH and IRT. For 17-OHP, a false positive result may be generated if the failure occurs for a normal sample.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Perkin Elmer issued an "Urgent Medical Device Recall" letter dated 1/25/12 to all customers and informed them about the possible issue and requested permission for service personnel to check their instrument. The customers were instructed that the instrument could not be used and the washer module required replacement. Customers were told to expect to be contacted by the firm's local representative for further details.
Quantity in Commerce 10 units
Distribution Worldwide Distribution - USA, including the states of Florida, Ohio, Oregon, Texas and the countries of Brazil, Belgium, France, Germany, and the UK.
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 = KHO and Original Applicant = PERKINELMER, INC.
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