Device recall
LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762.
- Recall number
- Z-0162-2027
- Event id
- 99776
- Status
- Ongoing
- FDA classification
- Class III
- Recalling firm
- Magellan Diagnostics, Inc.
- Report date
- Oct 21, 2026
- Posted
- Oct 15, 2026
- Initiated
- Sep 4, 2026
- Center classification date
- Oct 15, 2026
- Product code
- DOF
- Device type
- Lead, Atomic Absorption
- 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.
- Root cause
- Labeling Change Control
- Quantity
- 321 units
- Code info
- Model/Catalog Number: 70-6762. UD-DI: 00850355006000. Lot Number. 2530M-01.
- Distribution
- US Nationwide distribution in the states of CA, IN, PA, TX, NE, IL, MA, MO, KY.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K052549
- Location
- North Billerica, MA, United States