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Magellan Diagnostics, Inc.

13 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
(1)(2) LeadCare II Blood Lead Test Kit, (3)LeadCare II 5X Blood Lead Test Kit, (4)LeadCare recall (Z-1893-2026)Magellan Diagnostics, Inc.2026-04-17
LeadCare Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare Plus kit is provi recall (Z-1894-2026)Magellan Diagnostics, Inc.2026-04-17
LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is pro recall (Z-1895-2026)Magellan Diagnostics, Inc.2026-04-17
The LeadCare II Blood Lead Test System relies on electrochemistry and a unique Sensor to d recall (Z-0584-2026)Magellan Diagnostics, Inc.2025-11-21
LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the recall (Z-0219-2024)Magellan Diagnostics, Inc.2023-11-03
LeadCare II Blood Lead Test Kit Catalog Number 70-6762 recall (Z-1952-2021)Magellan Diagnostics, Inc.2021-07-01
LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004 recall (Z-1953-2021)Magellan Diagnostics, Inc.2021-07-01
LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098 recall (Z-1954-2021)Magellan Diagnostics, Inc.2021-07-01
LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls Product Usage: IVD t recall (Z-3035-2017)Magellan Diagnostics, Inc.2017-08-15
Magellan Diagnostics LeadCare and LeadCare II test Kits. Product Usage: The LeadCare Blood recall (Z-2225-2017)Magellan Diagnostics, Inc.2017-06-05
Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits. Product Usage: The LeadCa recall (Z-2226-2017)Magellan Diagnostics, Inc.2017-06-05
Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010 recall (Z-1925-2017)Magellan Diagnostics, Inc.2017-05-18
Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010 recall (Z-1926-2017)Magellan Diagnostics, Inc.2017-05-18

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Every clearance here is in the API, with alerts when new ones post.