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Device Recall LeadCare II Blood Lead Analyzer
Model / Serial
Part Numbers: 70-6760, 70-6529-R, 70-6760-P, and 70-6760-R. All LeadCare II and LeadCare Plus Blood Lead Analyzers with battery boards versions B and O.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution
Product Description
LeadCare II Blood Lead Analyzer || Part Numbers: 70-6760, 70-6529-R, 70-6760-P, || 70-6760-R. || Intended for in vitro (external) use only.
Manufacturer
Magellan Diagnostics, Inc.
1 Event
Recall of Device Recall LeadCare II Blood Lead Analyzer
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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
English
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