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.
FDA Recall Z-2121-2012 · Posted 2012-08-01
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Recalling FirmPerkinelmer
Recall StatusTerminated
Product CodeJLW
Date Initiated2012-06-27
Date Terminated2014-04-18
Product Quantity78 units
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
Firm 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. [email protected]
Root Cause
Component design/selection
Distribution Pattern
Worldwide Distribution - US (nationwide) and the countries of Australia, Belgium, Brazil, Egypt, France, Germany, Netherlands, Norway, Saudi Arabia,Switzerland,
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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