FDA-Device2018-04-11Class II

LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the quantitative measurement of lead in a whole blood sample.

Magellan Diagnostics, Inc.
Hazard

The incorrect placement of AA batteries into certain LeadCare Plus 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
79
Manufactured in
101 Billerica Ave Bldg 4, N/A, North Billerica, MA, United States
Products
LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the quantitative measurement of lead in a whole blood sample.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1296-2018

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