LeadCare¿ Plus Blood Lead Test Kit — Class II medical device recall Z-1894-2026
Ongoing recall by Magellan Diagnostics, Inc., reported 2026-04-29, distributed nationwide. Customers reported observing unexpectedly elevated results when using certain third-party micro-collection dev
| Recall number | Z-1894-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Magellan Diagnostics, Inc., North Billerica, MA, United States |
| Recall initiated | 2026-03-13 |
| Classified | 2026-04-17 |
| Reported by FDA | 2026-04-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BO, CA, CL, EC, ES, GH, GT, HK, HT, ID, IL, IN, IT, JP, KR, MX, NP, PE, PH, UY, VN, ZA |
| Quantity | 136 |
| UPC / GTIN / UDI-DI | 00850355006031 |
| Model numbers | 82-0004 |
Product
LeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare¿ Plus kit is provided with the following materials: " Sensors (4 containers of 24 each; 96 tests) " Treatment Reagent Tubes (4 packages of 24 each; 96 tests) " Calibration Button (1 @) " Lead Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL)
Reason for recall
Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.
Machine access
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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.