Magellan Diagnostics, Inc. recalls LeadCare II Blood Lead Test Kit.
- Recalling company
- 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 III – not likely to cause adverse health consequences
- Recall date
- Sep 4, 2026
- Reported
- Oct 21, 2026
- Distribution
- US Nationwide distribution in the states of CA, IN, PA, TX, NE, IL, MA, MO, KY.
- Status
- Ongoing
- Quantity
- 321 units
- Lot / codes
- Model/Catalog Number: 70-6762. UD-DI: 00850355006000. Lot Number. 2530M-01.
- Company location
- North Billerica, MA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0162-2027
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0162-2027 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.