Home / Recalls / Magellan Diagnostics, Inc. / Z-1926-2017

Z-1926-2017 Class I Terminated

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

Recall Details

Product Type
Devices
Report Date
May 24, 2017
Initiation Date
November 29, 2014
Termination Date
February 26, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1016

Product Description

Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010

Reason for Recall

LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concentrations in some blood samples. The issue is observed when blood samples are collected in tubes with lavender and tan rubber stoppers of the Becton Dickinson EDTA Vacutainer tubes, a collection device used with the testing system.

Distribution Pattern

Nationwide Distribution

Code Information

Kit lots: 1309BU,1310AU,1312BU,1404AU,1408BU

Other recalls by Magellan Diagnostics, Inc.

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  • 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-1296-2018 Class II — LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the quan (January 9, 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-2225-2017 Class I — Magellan Diagnostics LeadCare and LeadCare II test Kits. Product Usage: The (May 23, 2017)
  • Z-2226-2017 Class I — Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits. Product Usag (May 23, 2017)