Home / Recalls / Magellan Diagnostics, Inc. / Z-1296-2018

Z-1296-2018 Class II Terminated

Recalled by Magellan Diagnostics, Inc. — North Billerica, MA

Recall Details

Product Type
Devices
Report Date
April 11, 2018
Initiation Date
January 9, 2018
Termination Date
December 11, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
79

Product Description

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

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.

Distribution Pattern

Worldwide Distribution

Code Information

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

Other recalls by Magellan Diagnostics, Inc.

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  • Z-0219-2024 Class II — LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit i (September 19, 2023)
  • Z-1952-2021 Class I — LeadCare II Blood Lead Test Kit Catalog Number 70-6762 (May 7, 2021)
  • Z-1953-2021 Class I — LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004 (May 7, 2021)
  • Z-1954-2021 Class I — LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098 (May 7, 2021)
  • Z-0285-2019 Class II — Magellan LeadCare¿ II Blood Lead Test Kit. In Vitro Test for the measurement of (August 8, 2018)
  • Z-1295-2018 Class II — LeadCare II Blood Lead Analyzer Part Numbers: 70-6760, 70-6529-R, 70-6760-P, 7 (January 9, 2018)
  • Z-2226-2017 Class I — Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits. Product Usag (May 23, 2017)
  • Z-2225-2017 Class I — Magellan Diagnostics LeadCare and LeadCare II test Kits. Product Usage: The (May 23, 2017)
  • Z-3035-2017 Class II — LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls Product (January 20, 2016)