Perkin Elmer Genetic Screening Processor (GSP) Product Code: 2021-0010 Product Usage: The GSP instrument is a fully auto
FDA device recall Z-2121-2012 · posted 2012-08-01 · Terminated
Recall details
- Recalling firm
- Perkinelmer
- 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
- Action taken
- 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
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- JLW
- Quantity affected
- 78 units
- Distribution
- Worldwide Distribution - US (nationwide) and the countries of Australia, Belgium, Brazil, Egypt, France, Germany, Netherlands, Norway, Saudi Arabia,Switzerland,
- Date initiated
- 2012-06-27
- Date posted
- 2012-08-01
- Date terminated
- 2014-04-18
- 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 |