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U.S. Department of Health and Human Services

Class 2 Device Recall Genetic Screening Processor

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 Class 2 Recall
Genetic Screening Processor
see related information
Date Posted January 11, 2012
Recall Status1 Terminated on July 20, 2012
Recall Number Z-0603-2012
Recall Event ID 60390
Premarket Notification
510(K) Number
K090846 
Product Classification Radioimmunoassay, Thyroid-Stimulating Hormone - Product Code JLW
Product The GSP 2021-0010 (Genetic Screening Processor) instrument is a fully automated, high through put batch analyzer for time- resolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids. The chemistries running on the GSP instrument are used to test blood specimens dried on filter paper as an aid in screening newborns for congenital disorders.
Code Information Product Code 2021-0010
Recalling Firm/
Manufacturer
PerkinElmer LAS, Inc
940 Winter St
Waltham, Massachusetts 02451-1457
Manufacturer Reason
for Recall
Malfunction of the GSP disk remover unit may cause a punched disc to remain in the well during the measurement of the plate. This may cause a false negative screening result being reported for 17-OHP, resulting in failure to identify cases of congenital adrenal hyperplasia (CAH).
FDA Determined
Cause 2
DESIGN: Device Design
Action Recall (correction) letters were sent to all customers on October 24, 2011. An improved disk remover design is under development to eliminate the reported problem. Until the final field correction is available, customers should follow the precautions provided. The needed protocol update will be performed by the local service engineer. If customers observe an increase in the occurrence of the problem, the laboratory should contact their local PerkinElmer representative.
Quantity in Commerce 52
Distribution Worldwide Distribution - USA, including the states of: Missouri, Florida, Texas, Oregon, Alabama, Louisiana, New Jersey, Georgia, Virginia, Kentucky and the countries of: Australia, Belgium, Brazil, Egypt, France, Germany, Italy, Netherlands, Norway, Qatar, Saudi MOH, Switzerland, 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 = JLW and Original Applicant = PERKINELMER, INC.
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