Magellan Diagnostics, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 13 (7 Class I)
- 510(k) Clearances
- 2
- Inspections
- 7
- Compliance Actions
- 2
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0584-2026 | Class II | The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lea | February 23, 2024 |
| Z-0219-2024 | Class II | LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantitati | September 19, 2023 |
| Z-1952-2021 | Class I | LeadCare II Blood Lead Test Kit Catalog Number 70-6762 | May 7, 2021 |
| Z-1953-2021 | Class I | LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004 | May 7, 2021 |
| Z-1954-2021 | Class I | LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098 | May 7, 2021 |
| Z-0285-2019 | Class II | Magellan LeadCare¿ II Blood Lead Test Kit. In Vitro Test for the measurement of lead in fresh whole | August 8, 2018 |
| Z-1295-2018 | Class II | LeadCare II Blood Lead Analyzer Part Numbers: 70-6760, 70-6529-R, 70-6760-P, 70-6760-R. Intende | January 9, 2018 |
| Z-1296-2018 | Class II | LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the quantitative measurement | January 9, 2018 |
| Z-2225-2017 | Class I | Magellan Diagnostics LeadCare and LeadCare II test Kits. Product Usage: The LeadCare Blood Lead | May 23, 2017 |
| Z-2226-2017 | Class I | Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits. Product Usage: The LeadCare Blo | May 23, 2017 |
| Z-3035-2017 | Class II | LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls Product Usage: IVD test ki | January 20, 2016 |
| Z-1926-2017 | Class I | Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010 | November 29, 2014 |
| Z-1925-2017 | Class I | Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010 | November 29, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K142705 | LeadCare Plus Blood Lead Testing System | July 7, 2015 |
| K123563 | LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM | August 20, 2013 |