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PerkinElmer Life and Analytical Sciences, Wallac, OY
FDA Regulatory Profile
Summary
- Total Recalls
- 9
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1238-2019 | Class II | AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product | January 10, 2019 |
| Z-1239-2019 | Class II | AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product | January 10, 2019 |
| Z-1237-2019 | Class II | DELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code | January 10, 2019 |
| Z-1541-2018 | Class II | Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (curren | November 17, 2017 |
| Z-1692-2018 | Class II | NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected UDI Numbers: (01)0643814 | November 2, 2017 |
| Z-1220-2018 | Class III | AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determinat | September 25, 2017 |
| Z-1761-2017 | Class II | Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory is intended for use as | March 7, 2017 |
| Z-1107-2017 | Class II | Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Intended for in vitro quant | January 5, 2017 |
| Z-1108-2017 | Class II | Spare Disk Remover Module; Product Number: 61001820 Intended for in vitro quantitative and qualit | January 5, 2017 |