Recall Z-0162-2027 ยท DOF Lead, Atomic Absorption
Magellan Diagnostics, Inc.
LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762.
| Date | Oct 15, 2026 (initiated Sep 4, 2026) |
| Status | Open, Classified |
| 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 |
| Action | Magellan notified consignees on about September 4, 2026, via telephone call indicating a written notification of the recall would follow. On 09/17/2026, a notification letter was emailed to consignees with the following instructions: 1. Complete, sign, and return the CONFIRMATION OF NOTIFICATION FORM. 2. Review your inventory for the affected LeadCare II Blood Lead Test Kit lot identified. 3. Immediately discontinue use of any remaining affected kits. 4. Return any recalled product still in your possession to Magellan Diagnostics, Inc. for destruction. |
| Quantity | 321 units |
| Distribution | US Nationwide distribution in the states of CA, IN, PA, TX, NE, IL, MA, MO, KY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052549 | LEADCARE II BLOOD LEAD TESTING SYSTEM Esa Biosciences, Inc., Oct 6, 2005 |