Information on the LeadCare Test Kit “Controls Out of Range-Low”
(“COOR-LO”) Recall

July 20, 2021

We are experiencing very high call and email volumes at this time. Our Product Support Team is processing requests as quickly as possible. Thank you for your patience as we work to respond to your inquiries.

Please note LeadCare Analyzers (LeadCare^® II, LeadCare Plus^® and LeadCare Ultra^®) ARE NOT impacted by this recall. You are still able to use this instrumentation.

Please review the test kit LOT numbers below that are impacted by the recall.

FDA Recall Notifications:

Lots Impacted in the Initial COOR-LO Recall:

LeadCare II : 2013M, 2014M, 2015M, 2016M and 2017M
(Cat No. 70-6762)
LeadCare Plus & LeadCare Ultra: 2011MU
(Cat No 82-0004 and Cat No 70-8098)

Download the Initial Recall Notification

CDC Information Related to the COOR-LO Recall:

Lots Impacted in the Expanded (2nd) COOR-LO Recall:

LeadCare II: 2101M, 2103M, 2105M, 2106M, and 2107M
(Cat No 70-6762)
LeadCare Plus & LeadCare Ultra: 2104MU and 2108MU
(Cat No 82-0004 and Cat No 70-8098)

Download the Expanded (2nd) Recall Notification

Press Release: Magellan Diagnostics, Inc. Expands Voluntary Recall of LeadCare® Test Kits

Download September 1, 2021 Press Release

Lots Impacted in the Expanded (3rd) COOR-LO Recall:

LeadCare II: 2012M-08, 2012M-09, 2012M-10, 2012M-11, 2012M-12, 2102M-13, 2012M-14, 2018M, 2102M, 2109M, 2110M, 2111M, 2112M, 2113M, 7114M, 2114M, 2115M
(Cat No 70-6762)

Download the Expanded (3rd) Recall Notification