Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number:… — Class I medical device recall Z-1926-2017
Terminated recall by Magellan Diagnostics, Inc., reported 2017-05-24, distributed nationwide. LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concentrations in so
| Recall number | Z-1926-2017 |
|---|---|
| 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 | 2014-11-29 |
| Classified | 2017-05-17 |
| Reported by FDA | 2017-05-24 |
| Terminated | 2022-02-26 |
| Distributed | Nationwide (US) |
| Quantity | 1,016 |
| Lot numbers | 1309BU, 1310AU, 1312BU, 1404AU, 1408BU |
| Model numbers | 80-0010 |
Product
Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010
Reason for recall
LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concentrations in some blood samples. The issue is observed when blood samples are collected in tubes with lavender and tan rubber stoppers of the Becton Dickinson EDTA Vacutainer tubes, a collection device used with the testing system.
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-1926-2017. 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.