Magellan Diagnostics, Inc. Recalls

4 recalls on record in the United States

medical: 4
medical Class II
2026-04-29

Magellan Diagnostics, Inc. recalls LeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004

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.

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medical Class II
2026-04-29

Magellan Diagnostics, Inc. recalls (1)(2) LeadCare¿ II Blood Lead Test Kit, (3)LeadCare¿ II 5X

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.

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medical Class II
2026-04-29

Magellan Diagnostics, Inc. recalls LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098

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.

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medical Class III
2026-10-21

Magellan Diagnostics, Inc. recalls LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-67

In kit sub-lot 2530M-01 the date of expiration printed on the outer labeling may indicate the wrong expiration date of July 22, 2026 while the correct expiration date is July 13, 2026. If used the system will display an error message and prevent the operator from running the test. Resulting in delayed results.

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