PerkinElmer Health Sciences, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 10
- 510(k) Clearances
- 0
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2264-2020 | Class III | PerkinElmer 226 Sample Collection Device | December 19, 2017 |
| Z-2756-2017 | Class III | PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collection Device is intended | May 31, 2017 |
| Z-1100-2017 | Class III | AutoDELFIA¿ Plate Processor , Fluorometer, for clinical use Product Number: 1235-5110 Product | December 21, 2016 |
| Z-1102-2017 | Class III | DELFIA¿ PC with V3.0 Software, Fluorometer, for clinical use Product Number: 1235-8100 Product | December 21, 2016 |
| Z-1101-2017 | Class III | Program Update Package AutoDELFIA¿ 3.0, Fluorometer, for clinical use Product Number: 1235-8110 | December 21, 2016 |
| Z-0897-2017 | Class III | EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-quantitative determinat | December 5, 2016 |
| Z-0902-2017 | Class II | Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Software Version 1.0 Specimen | December 1, 2016 |
| Z-0779-2017 | Class III | DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum | November 16, 2016 |
| Z-2153-2014 | Class II | Panthera-Puncher 9 . Panthera-Puncher 9 is a sample transfer instrument for professional use. T | July 1, 2014 |
| Z-2166-2014 | Class II | PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Product Code: 5002-0500 | June 27, 2014 |