Reported Apr 11, 2018 · Terminated
LeadCare II Blood Lead Analyzer Part Numbers: 70-6760, 70-6529-R, 70-6760-P, 70-6760-R. Intended for in vitro…
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
- II Blood Lead Analyzer Part Numbers70-6760, 70-6529-R, 70-6760-P, 70-6760-R. Intended for in vitro (external) use only
- Lot codes and dates
- Part Numbers70-6760, 70-6529-R, 70-6760-P, and 70-6760-R. All LeadCare II and LeadCare Plus Blood Lead Analyzers with battery boards versions B and O
- Amount recalled
- 6,143
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 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.
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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