Magellan Diagnostics, Inc.: Medical Device Recall in 2021 - (Recall #: Z-1954-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098

Product Classification:

Class I

Date Initiated: May 7, 2021

Date Posted: July 7, 2021

Recall Number: Z-1954-2021

Event ID: 87992

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.

Status: Terminated

Product Quantity: 441 kits (192 tests/kit = 84,672 tests)

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated