The GSP 2021-0010 (Genetic Screening Processor) instrument is a fully automated, high through put batch analyzer for tim
FDA device recall Z-0603-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- PerkinElmer LAS, Inc
- Reason for recall
- 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).
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JLW
- Quantity affected
- 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, E
- Date initiated
- 2011-10-24
- Date posted
- 2012-01-11
- Date terminated
- 2012-07-20
- Location
- Waltham, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GSP INSTRUMENT AND GSP NEONATAL HTSH KIT (K090846) | Perkinelmer, Inc. | 2009-09-03 |