Recall Z-2121-2012 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Perkinelmer
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 use
| Date | Aug 1, 2012 (initiated Jun 27, 2012) |
| Status | Terminated |
| Reason | Contamination from GSP Shaker unit results in decreased signal activity of assay measurements for Genetic Screening for Neonatal IRT, TSH and IRT |
| Root cause | Component design/selection |
| 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. Technical.Support@PerkinElmer.com |
| Quantity | 78 units |
| Distribution | Worldwide Distribution - US (nationwide) and the countries of Australia, Belgium, Brazil, Egypt, France, Germany, Netherlands, Norway, Saudi Arabia,Switzerland, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090846 | GSP INSTRUMENT AND GSP NEONATAL HTSH KIT Perkinelmer, Inc., Sep 3, 2009 |