| Class 2 Device Recall Genetic Screening Processor | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = JLW
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