LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004 — Class I medical device recall Z-1953-2021
Terminated recall by Magellan Diagnostics, Inc., reported 2021-07-07, distributed nationwide. Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a
| Recall number | Z-1953-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Magellan Diagnostics, Inc., North Billerica, MA, United States |
| Recall initiated | 2021-05-07 |
| Classified | 2021-07-01 |
| Reported by FDA | 2021-07-07 |
| Terminated | 2023-10-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, HK, IN, IT, NZ, PE, PH, VN |
| Reason classes | chemical contamination |
| Lot numbers | 1ST, 2011MU, 25MAR22 |
| Model numbers | 82-0004 |
Product
LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1953-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.