FDA-Device2018-04-11Class II
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.
Magellan Diagnostics, Inc.
Hazard
The incorrect placement of AA batteries into certain LeadCare II Blood Lead Analyzer may cause the batteries to overheat, and the chance that a user could burn their fingers if the batteries are removed while hot.
Sold states
Worldwide Distribution
Affected count
6,143
Manufactured in
101 Billerica Ave Bldg 4, N/A, North Billerica, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1295-2018Don't want to check this manually?
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