FDA recall Z-1952-2021

Product

LeadCare II Blood Lead Test Kit Catalog Number 70-6762

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

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

Key facts

Status

Terminated

Initiation date

2021-05-07

Report date

2021-07-07

Termination date

2023-10-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Billerica, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1952-2021