Magellan Diagnostics, Inc.: Lead, Atomic Absorption
Magellan Diagnostics LeadCare II Recall Summary Magellan Diagnostics is recalling certain LeadCare II Blood Lead Test Kits (Model 70-6762, sub-lot 2530M-01) because the printed expiration date on the box is incorrect—it shows July 22, 2026 instead of the actual expiration date of July 13, 2026. If used after the correct expiration date, the device will display an error message and prevent the test from running, causing delayed results. The affected kits were distributed nationwide across multiple states.
- Recalling firm
- Magellan Diagnostics, Inc.
- Product
- LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762.
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-09-04
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of CA, IN, PA, TX, NE, IL, MA, MO, KY.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/e8257d68-b0a3-4a1b-8d77-bd67e827b2f5