Reported Apr 11, 2018 · Terminated

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

Magellan Diagnostics, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Magellan Diagnostics, Inc. · 101 Billerica Ave Bldg 4 · North Billerica, MA · 01862-1271

Is this the product you have?

  • LeadCare
  • Plus Blood Lead Analyzer Part Number82-0001 Intended for the quantitative measurement of lead in a whole blood sample
Lot codes and dates
  • Part Number82-0001. All LeadCare II and LeadCare Plus Blood Lead Analyzers with battery boards versions B and O
Amount recalled
79

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

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.

This product could cause temporary or reversible health problems — stop using it.

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 11, 2020 · Data as of Sep 19, 5:29 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.