FDA Device recall Z-1953-2021
LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004
- FDA Device
- Class I
- terminated
- Published 2021-07-07
On 2021-07-07 the FDA classified a Class I recall of LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004 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-1953-2021 |
| 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 Plus Blood Lead Test Kit Catalog Number 82-0004
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.
Other recalls by Magellan Diagnostics
- LeadCare II Blood Lead Test Kit
FDA Device · Class III · 2026-10-21 · Magellan Diagnostics - LeadCare¿ Plus Blood Lead Test Kit
FDA Device · Class II · 2026-04-29 · Magellan Diagnostics - LeadCare Ultra Blood Lead Test Kit
FDA Device · Class II · 2026-04-29 · Magellan Diagnostics - (1)(2) LeadCare¿ II Blood Lead Test Kit, (3)LeadCare¿ II 5X Blood Lead Test Kit, (4)LeadCare¿ II 9X Blood Lead Test Kit
FDA Device · Class II · 2026-04-29 · Magellan Diagnostics - The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in whole blood
FDA Device · Class II · 2025-12-03 · Magellan Diagnostics
All Magellan Diagnostics recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1953-2021%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.