FDA Device recall Z-1952-2021
LeadCare II Blood Lead Test Kit Catalog Number 70-6762
- FDA Device
- Class I
- terminated
- Published 2021-07-07
On 2021-07-07 the FDA classified a Class I recall of LeadCare II Blood Lead Test Kit Catalog Number 70-6762 by Magellan Diagnostics, citing 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 le….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1952-2021 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2021-05-07 |
| Published | 2021-07-07 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Magellan Diagnostics |
| Distribution | US |
Product
LeadCare II Blood Lead Test Kit Catalog Number 70-6762
Reason
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.
Identifiers
| code_info | Lot Numbers/Expiration Date: 2013M - 22APR22; 2014M - 29APR22; 2015M - 12MAY22; 2016M - 19MAY22; 2017M - 10JUN22; 1s…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1952-2021%22
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