FDA-Device2026-10-21Class IIIMISBRANDING

Magellan LeadCare II Blood Lead Test Kit recalled for incorrect expiration date labeling

EXPIRATION DATE ERRORNationwide distributionMedical devices

What this means

Some LeadCare II Blood Lead Test Kits (model 70-6762, sub-lot 2530M-01) have an incorrect expiration date printed on the outer label. The label shows July 22, 2026, but the correct date is July 13, 2026. When used after the correct expiration date, the system will display an error and prevent the test from running, causing delayed results.

  • Check if you have LeadCare II model 70-6762 from sub-lot 2530M-01 with an expiration date of July 22, 2026 printed on the label.
  • Do not use kits from this sub-lot after July 13, 2026.
  • Contact Magellan Diagnostics, Inc. for guidance on replacement or disposal of affected units.
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The agency's original wording
Hazard

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.

Intended for
All ages
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of CA, IN, PA, TX, NE, IL, MA, MO, KY.
Affected count
321 units
Manufactured in
101 Billerica Ave Bldg 4, North Billerica, MA, United States
Products
LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0162-2027

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