FDAFDA recall Z-0162-2027 · Oct 21, 2026
Magellan Diagnostics, Inc.: LeadCare II Blood Lead Test Kit recall
Recall found
Product
LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762.
Reason for recall
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class III: use of or exposure to the product is not likely to cause health problems.
- Status
- Ongoing
- Codes, lots and dates
- Model/Catalog Number: 70-6762. UD-DI: 00850355006000. Lot Number. 2530M-01.
- Quantity
- 321 units
- Distribution
- US Nationwide distribution in the states of CA, IN, PA, TX, NE, IL, MA, MO, KY.
- Recalling firm
- Magellan Diagnostics, Inc., North Billerica, MA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-09-04
Source: openFDA enforcement record Z-0162-2027 · search recall number Z-0162-2027 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 31, 2026, 6:32 AM EDT. The agency notice is the final word.