Medical device recalls Moderate risk

LeadCare II Blood Lead Analyzer Part Numbers recalled over fire hazard

Recall date
January 9, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Magellan Diagnostics, Inc. recalls LeadCare II Blood Lead Analyzer Part Numbers: 70-6760, 70-6529-R, 70-6760-P, 70-6760-R. Intended for in vitro (external…
Recall number
Z-1295-2018
FDA classification
Class II
Brand / firm
Magellan Diagnostics, Inc.
Sold / distributed
Worldwide Distribution

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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