# Class III recall Z-0162-2027: Magellan Diagnostics, Inc.

**Predicate Speed & CAPA Advisory Opportunity Score:** 46/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0162-2027 |
| Recalling firm | Magellan Diagnostics, Inc. |
| Classification | Class III |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| 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. |
| Quantity | 321 units |
| Distribution | US Nationwide distribution in the states of CA, IN, PA, TX, NE, IL, MA, MO, KY. |
| Recall initiated | 2026-09-04 |
| Reported | 2026-10-21 |
| Firm location | North Billerica, MA, United States |

## Why this score
- Class III recall: lower risk.
- Recall is still ongoing.
- Posted 15 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0162-2027%22). Last refreshed: 2026-11-04T21:30:53.898Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.