FDA Device recall Z-1954-2021
LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098
- FDA Device
- Class I
- terminated
- Published 2021-07-07
On 2021-07-07 the FDA classified a Class I recall of LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098 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-1954-2021 |
| 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 Ultra Blood Lead Test Kit Catalog Number 70-8098
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: 2011MU - 25MAR22. 1st expansion 6/21/2021: 2104MU - 25AUG22; 2108MU - 31MAR22. |
|---|
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-1954-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.