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Device Recall LeadCare Plus Blood Lead Testing System
Model / Serial
Kit lots: 1309BU,1310AU,1312BU,1404AU,1408BU
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution
Product Description
Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits || Part Number: 80-0010
Manufacturer
Magellan Diagnostics, Inc.
1 Event
Recall of Device Recall LeadCare Plus Blood Lead Testing System
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Manufacturer
Magellan Diagnostics, Inc.
Manufacturer Address
Magellan Diagnostics, Inc., 101 Billerica Ave Bldg 4, North Billerica MA 01862-1271
Manufacturer Parent Company (2017)
Meridian Bioscience, Inc.
Source
USFDA
Language
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