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U.S. Department of Health and Human Services

Class 2 Device Recall Perkin Elmer

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 Class 2 Recall
Perkin Elmer
see related information
Date Posted February 28, 2012
Recall Status1 Terminated on March 06, 2013
Recall Number Z-1116-2012
Recall Event ID 61031
Premarket Notification
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
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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 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 = KHO and Original Applicant = PERKINELMER, INC.
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