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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 Device Recall Genetic Screening Processor see related information
Date Initiated by Firm October 24, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on July 20, 2012
Recall Number Z-0603-2012
Recall Event ID 60390
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 MA 02451-1457
For Additional Information Contact
781-663-5818
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		 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 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 = JLW and Original Applicant = PERKINELMER, INC.
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