Magellan Diagnostics, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1296-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 9, 2018

Date Posted: April 11, 2018

Recall Number: Z-1296-2018

Event ID: 79279

Reason for Recall:

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.

Status: Terminated

Product Quantity: 79

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

Voluntary or Mandated:

Voluntary: Firm initiated