Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-1296-2018

January 09, 2018

Class II

Product summary

Firm
Magellan Diagnostics, Inc.
Event
Event 79279
Status
Terminated
Classification
Class II
Quantity
79
Official record key
device-enforcement:Z-1296-2018

Official wording

Reason: 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.

Code information: Part Number: 82-0001. All LeadCare II and LeadCare Plus Blood Lead Analyzers with battery boards versions B and O.

Distribution pattern: Worldwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.