Product Wiki · Recalls · U.S. FDA — Device Enforcement

Perkin Elmer Genetic Screening Processor (GSP) Product Code: 2021-0010 — recall Z-2121-2012

U.S. FDA — Device Enforcement · United States · 2012-06-27 · Class II

As described by U.S. FDA — Device Enforcement: 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 / quali

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2121-2012
Date of alert
2012-06-27
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Perkinelmer
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide Distribution - US (nationwide) and the countries of Australia, Belgium, Brazil, Egypt, France, Germany, Netherlands, Norway, Saudi Arabia,Switzerland,
Reported risk: Contamination from GSP Shaker unit results in decreased signal activity of assay measurements for Genetic Screening for Neonatal IRT, TSH and IRT
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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