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U.S. Department of Health and Human Services

Class 2 Device Recall Perkin Elmer Genetic Screening Processor (GSP)

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  Class 2 Device Recall Perkin Elmer Genetic Screening Processor (GSP) see related information
Date Initiated by Firm June 27, 2012
Date Posted August 01, 2012
Recall Status1 Terminated 3 on April 18, 2014
Recall Number Z-2121-2012
Recall Event ID 62512
510(K)Number K090846  
Product Classification Radioimmunoassay, thyroid-stimulating hormone - Product Code JLW
Product Perkin Elmer Genetic Screening Processor (GSP)
Product Code: 2021-0010

Product Usage: The GSP instrument is a fully automated, high throughput 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 reagent kits running on the GSP instrument are used to test blood specimens dried on filter paper as an aid in screening newborns for congenital disorders. Currently assays for the determination of T4, TSH, 17OHP, IRT and GALT are cleared and available for use with the GSP instrument.
Code Information Serial Numbers: 20210001 through 20210078 
Recalling Firm/
Manufacturer		 Perkinelmer
940 Winter Street
Waltham MA 02451
Manufacturer Reason
for Recall		 Contamination from GSP Shaker unit results in decreased signal activity of assay measurements for Genetic Screening for Neonatal IRT, TSH and IRT
FDA Determined
Cause 2		 Component design/selection
Action PerkinElmer sent an Urgent: Medical Device Recall letter dated June 27, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter states that replacement units of the recalled product will be installed as soon as they are available. Customers were instructed to complete and return the response form attached. For further information contact your local PerkinElmer representative or GS. Technical.Support@PerkinElmer.com
Quantity in Commerce 78 units
Distribution Worldwide Distribution - US (nationwide) and the countries of Australia, Belgium, Brazil, Egypt, France, Germany, Netherlands, Norway, Saudi Arabia,Switzerland,
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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