Home / Recalls / Magellan Diagnostics, Inc. / Z-1954-2021

Z-1954-2021 Class I Terminated

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

Recall Details

Product Type
Devices
Report Date
July 7, 2021
Initiation Date
May 7, 2021
Termination Date
October 24, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
441 kits (192 tests/kit = 84,672 tests)

Product Description

LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098

Reason for Recall

Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may cause the underestimation of blood lead levels in patient samples.

Distribution Pattern

Worldwide distribution. US nationwide including Puerto Rico; Canada, Vietnam, India, Italy, Peru, New Zealand, Australia, Hong Kong, and Philippines.

Code Information

Lot Numbers/Expiration Date: 2011MU - 25MAR22. 1st expansion 6/21/2021: 2104MU - 25AUG22; 2108MU - 31MAR22.

Other recalls by Magellan Diagnostics, Inc.

  • Z-0584-2026 Class II — The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a unique (February 23, 2024)
  • 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-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)
  • Z-3035-2017 Class II — LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls Product (January 20, 2016)