FDA Device recall Z-3035-2017
LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls Product Usage: IVD test kit for the detection of lead in blood
- FDA Device
- Class II
- terminated
- Published 2017-08-23
On 2017-08-23 the FDA classified a Class II recall of LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls Product Usage: IVD test kit for the detection of lead in blood by Magellan Diagnostics, citing leadCare II Test Kits controls out of range.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3035-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-20 |
| Published | 2017-08-23 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Magellan Diagnostics |
| Distribution | US |
Product
LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls Product Usage: IVD test kit for the detection of lead in blood. The kit consists of sensors, treatment reagent, lead controls (two levels), heparinized capillary tubes and plungers, transfer droppers and a calibration button. The LeadCare II Lead Controls packaged in the kit lots listed in #2 below are the subject of this recall (Field Correction) action.
Reason
LeadCare II Test Kits controls out of range
Identifiers
| code_info | Lot # :1507N Exp Date: 1/27/17; Lot # :1508N Exp Date: 2/27/17; Lot # :1510N Exp Date: 4/19/17; Lot # :1511M Exp…Lot # :1507N Exp Date: 1/27/17; Lot # :1508N Exp Date: 2/27/17; Lot # :1510N Exp Date: 4/19/17; Lot # :1511M Exp Date: 5/3/17 Lot # :1511N Exp Date: 5/17/17 Lot # :1512M Exp Date: 6/2/17 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 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-3035-2017%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.