Magellan Diagnostics, Inc.: Medical Device Recall in 2021 - (Recall #: Z-1952-2021)

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 II Blood Lead Test Kit Catalog Number 70-6762

Product Classification:

Class I

Date Initiated: May 7, 2021

Date Posted: July 7, 2021

Recall Number: Z-1952-2021

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: 387,281 kits (48 tests/kit=1,757,040 tests)

Code Information:

Lot Numbers/Expiration Date: 2013M - 22APR22; 2014M - 29APR22; 2015M - 12MAY22; 2016M - 19MAY22; 2017M - 10JUN22; 1st expansion 6/21/2021: 2101M - 28JUL22; 2103M - 18AUG22; 2105M - 11SEP22; 2106M - 21JAN22; 2107M - 30SEP22; 2nd expansion 8/30/2021; 2012M Sublots: -08, -09, -10, -11, -12, -13, -14 - 08APR22; 2018M - 06JUN22; 2102M - 30SEP21; 2109M - 15OCT22; 2110M - 29OCT22; 2111M - 31MAY22; 2112M - 13NOV22; 2113M - 30JUN22; 2114M - 17DEC22; 2115M - 29DEC22; 7114M - 17DEC22.

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