Magellan Diagnostics LeadCare and LeadCare II test Kits — Class I medical device recall Z-2225-2017
Terminated recall by Magellan Diagnostics, Inc., reported 2017-06-14, distributed nationwide. Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare sy
| Recall number | Z-2225-2017 |
|---|---|
| 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 | 2017-05-23 |
| Classified | 2017-06-05 |
| Reported by FDA | 2017-06-14 |
| Terminated | 2021-07-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BO, CA, CH, CL, CN, CO, DE, ES, GB, IL, IN, IT, JP, KR, LK, NL, NP, NZ, PA, PE, PL, PT, SE, TT, VN, ZA |
Product
Magellan Diagnostics LeadCare and LeadCare II test Kits. Product Usage: The LeadCare Blood Lead Test Kit is for in vitro diagnostic use only. The Test Kit is for the quantitative measurement of lead in fresh whole blood. This product is for professional use only. Sensors and Treatment Reagent of the Test Kit are specific for lead only. Contents of this LeadCare Blood Lead Test Kit must only be used with a LeadCare Analyzer and Blood Lead Testing System.
Reason for recall
Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems
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-2225-2017. 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.