Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1893-2026 — (1)(2) LeadCare¿ II Blood Lead Test Kit, (3)LeadCare¿ II 5X Blood Lead Test Kit, (4)LeadCare¿ II 9X Blood Lead Test Kit ; Catalog Number(s): (1) 70-6762, (2) 70-6762RUO, (3) 70-8404 (Box containing 5 Test Kits), (4) 70-9000 (Box containing 9 test kits); The LeadCare II kit is provided with the fol

U.S. FDA — Device Enforcement · United States · 2026-03-13 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1893-2026
Date of alert: 2026-03-13
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Magellan Diagnostics, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00850355006000

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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