Enforcement Report - Week of August 8, 2012
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Product Detail
| Product Description | 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. |
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| Recall Number | Z-2121-2012 |
| Classification | Class II |
| Code Info | Serial Numbers: 20210001 through 20210078 |
| Product Distributed Qty | 78 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 |
Event Detail
| Event Id | 62512 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Perkinelmer |
| City | Waltham |
| State | MA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-06-27 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution - US (nationwide) and the countries of Australia, Belgium, Brazil, Egypt, France, Germany, Netherlands, Norway, Saudi Arabia,Switzerland, |
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