LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762. recall (Magellan Diagnostics, Inc.)
Medical deviceClass IIIOngoing
Summary: Magellan Diagnostics, Inc. is recalling 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.
What is being recalled
LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762.
Why
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.
How serious is it
Class III is the least serious level: using or being exposed to this product is not likely to cause health problems, but it breaks FDA rules.
Where it was sold
US Nationwide distribution in the states of CA, IN, PA, TX, NE, IL, MA, MO, KY. (states named: California, Illinois, Indiana, Kentucky, Massachusetts, Missouri, Nebraska, Pennsylvania, Texas)
How to tell if yours is affected
Model/Catalog Number: 70-6762. UD-DI: 00850355006000. Lot Number. 2530M-01.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-0162-2027 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class III |
| Status | Ongoing |
| Recall started | September 4, 2026 |
| Reported | October 21, 2026 |
| Company | Magellan Diagnostics, Inc. |
| Company location | North Billerica, MA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 321 units |
More recalls from Magellan Diagnostics, Inc. · all medical device recalls · recalls from September 2026