Magellan Diagnostics product 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 Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the quantitative measurement of lead in a whole blo…

Recall number

Z-1296-2018

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 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.

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