FDA Device recall Z-0162-2027
LeadCare II Blood Lead Test Kit
- FDA Device
- Class III
- ongoing
- Published 2026-10-21
On 2026-10-21 the FDA classified a Class III recall of LeadCare II Blood Lead Test Kit by Magellan Diagnostics, citing in kit sub-lot 2530M-01 the date of expiration printed on the outer labeling may indicate the wrong expiration date of July 22, 2026 while the correct expiration date is July 13,….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0162-2027 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2026-09-04 |
| Published | 2026-10-21 |
| Last updated | 2026-10-27 05:30 UTC |
| Company | Magellan Diagnostics |
| Distribution | US |
Product
LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762.
Reason
In kit sub-lot 2530M-01 the date of expiration printed on the outer labeling may indicate the wrong expiration date of July 22, 2026 while the correct expiration date is July 13, 2026. If used the system will display an error message and prevent the operator from running the test. Resulting in delayed results.
Identifiers
| code_info | Model/Catalog Number: 70-6762. UD-DI: 00850355006000. Lot Number. 2530M-01. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-27 05:30 UTC. Current status: ongoing.
Other recalls by 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 - LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only
FDA Device · Class II · 2023-11-15 · Magellan Diagnostics
All Magellan Diagnostics recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0162-2027%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.