Recall Z-0603-2012 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
PerkinElmer LAS, Inc
The GSP 2021-0010 (Genetic Screening Processor) instrument is a fully automated, high through put 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 chemistries running on the GSP instrument are used to test blood specimens dried on filter paper
| Date | Jan 11, 2012 (initiated Oct 24, 2011) |
| Status | Terminated |
| Reason | Malfunction of the GSP disk remover unit may cause a punched disc to remain in the well during the measurement of the plate. This may cause a false negative screening result being reported for 17-OHP, resulting in failure to identify cases of congenital adrenal hyperplasia (CAH). |
| Root cause | Device Design |
| Action | Recall (correction) letters were sent to all customers on October 24, 2011. An improved disk remover design is under development to eliminate the reported problem. Until the final field correction is available, customers should follow the precautions provided. The needed protocol update will be performed by the local service engineer. If customers observe an increase in the occurrence of the problem, the laboratory should contact their local PerkinElmer representative. |
| Quantity | 52 |
| Distribution | Worldwide Distribution - USA, including the states of: Missouri, Florida, Texas, Oregon, Alabama, Louisiana, New Jersey, Georgia, Virginia, Kentucky and the countries of: Australia, Belgium, Brazil, Egypt, France, Germany, Italy, Netherlands, Norway, Qatar, Saudi MOH, Switzerland, and the UK. |
| 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 |