Official recall record

(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): (

US FDA — Medical Devices · 2026-03-13 · United StatesClass II

Issuing authority: US FDA — Medical Devices
Recall initiated by firm: 2026-03-13
Country of alert: United States
Alert level: Class II
Alert type: recall
Barcode (EAN/GTIN): 00850355006000
Brand on record: Magellan Diagnostics, Inc.

What the authority reported

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.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

More recalls: US FDA — Medical Devices · United States · all filters

Same barcode in other registries

The same EAN appears in 3 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.

2022-05-25 · US FDA — Medical Devices
MAGELLAN DIAGNOSTICS LeadCare II Blood Lead Test Kit Rapid Test Kit LeadCare II General Chemistry Blood Lead Test Whole
2023-09-19 · US FDA — Medical Devices
LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantitative measurement of le
2026-09-04 · US FDA — Medical Devices
LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762.

Other recalls from this brand

2026-09-04 · US FDA — Medical Devices
LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762.
2026-03-13 · US FDA — Medical Devices
LeadCare Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare Plus kit is provided with the follo
2026-03-13 · US FDA — Medical Devices
LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the fol

All 5 official recall notices naming Magellan Diagnostics, Inc. on this site →

ProductGuru Recalls republishes official safety information with attribution. We are not the issuing authority and this page is not advice. If this product is a medical device or medication, speak to a doctor or pharmacist. Found an error? Report it — corrections are published.