Reported Aug 8, 2012 · Terminated
Perkin Elmer Genetic Screening Processor (GSP) Product Code: 2021-0010 Product Usage: The GSP instrument is a fully…
Perkinelmer
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Perkinelmer · 940 Winter Street · Waltham, MA · 02451
Is this the product you have?
- Perkin Elmer Genetic
- Screening Processor (GSP) Product Code2021-0010
- Product UsageThe 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
- Lot codes and dates
- Serial Numbers20210001 through 20210078
- Amount recalled
- 78 units
Where it was sold
- Nationwide
Why it was recalled
Contamination from GSP Shaker unit results in decreased signal activity of assay measurements for Genetic Screening for Neonatal IRT, TSH and IRT
This product could cause temporary or reversible health problems — stop using it.
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