FDA recall, , Low risk
Magellan Diagnostics LeadCare II Blood Lead Test Kit
The LeadCare II Blood Lead Test Kit may show a wrong expiration date, causing an error and delayed results.
Summary by Recall Canary from the FDA notice
What happened
Magellan Diagnostics, Inc. is recalling the LeadCare II Blood Lead Test Kit because in a sub-lot 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.
The company began the recall on September 4, 2026, and it was added to the FDA's Enforcement Report on October 15, 2026. The recall involves 321 units distributed nationwide in the states of California, Illinois, Indiana, Kentucky, Massachusetts, Missouri, Nebraska, Pennsylvania and Texas.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
Match the model number and lot code listed under your product.
LeadCare II Blood Lead Test Kit
- Model number
- 70-6762
- Lot code
- 2530M-01
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of California, Indiana, Pennsylvania, Texas, Nebraska, Illinois, Massachusetts, Missouri, Kentucky.
- Company
- Magellan Diagnostics, Inc.
- Hazard
- Labeling error
- Risk
Low risk
Using it is unlikely to cause health problems.
FDA Class III recall · How risk is rated
- Event ID
- 99776
- Recall number
- Z-0162-2027
- Quantity recalled
- 321 units
All recalls from Magellan Diagnostics, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
