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Class IIIOngoing

Magellan Diagnostics, Inc. recalls LeadCare II Blood Lead Test Kit

Recall date · record updated Oct 21, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Magellan Diagnostics, Inc.
Reason
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.
Hazard
FDA Class III: not likely to cause adverse health consequences (FDA definition).
Who’s affected
US Nationwide distribution in the states of CA, IN, PA, TX, NE, IL, MA, MO, KY.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99776…

Products

  1. LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762.

    Codes/lots: Model/Catalog Number: 70-6762. UD-DI: 00850355006000. Lot Number. 2530M-01.Quantity: 321 unitsRecall no. Z-0162-2027Class III

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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