FDA recall, , Moderate risk
Magellan Diagnostics LeadCare Blood Lead Test Kits
LeadCare blood lead test kits may show falsely elevated results when used with certain third-party micro-collection devices.
Summary by Recall Canary from the FDA notice
What happened
Magellan Diagnostics, Inc., of North Billerica, Massachusetts, recalled LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Test Kits after customers reported unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems.
False positive lead results may cause delayed results and additional unnecessary testing. The recall began March 13, 2026, and was added to the FDA's Enforcement Report on April 17, 2026. The kits were distributed nationwide and in countries including Argentina, Australia, Canada, India, and the UAE.
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 yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
Product details
(1)(2) LeadCare¿ II Blood Lead Test Kit, (3)LeadCare¿ II 5X Blood Lead Test Kit, (4)LeadCare¿ II 9X Blood Lead Test Kit ;
Catalog Number(s): (1) 70-6762, (2) 70-6762RUO, (3) 70-8404 (Box containing 5 Test Kits), (4) 70-9000 (Box containing 9 test kits);
The LeadCare II kit is provided with the following materials: " Sensors (2 Containers of 24 sensors each;
48 tests) " Treatment Reagent Tubes (2 packages of 24 tubes each;
48 tests) " Heparinized Capillary Tubes/Plungers (50 @) " Transfer Droppers (50 @) " Calibration Button (1 @) " Lead Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL)- UDI-DI
- 00850355006000
- 00850355006086
- 00850355006093
- Lot code
- ALL lots and ALL sublots; Catalog Number(s): (3) 70-8404; UDI-DI: 00850355006086; ALL lots and ALL sublots; Catalog Number(s): (4) 70-9000; UDI-DI: 00850355006093; ALL lots and ALL sublots;
Product details
LeadCare¿ Plus Blood Lead Test Kit;
Catalog Number: 82-0004;
The LeadCare¿ Plus kit is provided with the following materials: " Sensors (4 containers of 24 each;
96 tests) " Treatment Reagent Tubes (4 packages of 24 each;
96 tests) " Calibration Button (1 @) " Lead Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL)- UDI-DI
- 00850355006031
- Lot code
- ALL lots and ALL sublots;
Product details
LeadCare Ultra Blood Lead Test Kit;
Catalog Number: 70-8098;
The LeadCare Ultra kit is provided with the following materials: " Sensors (8 containers of 24 each;
192 tests) " Treatment Reagent Tubes (8 containers of 24 each;
192 tests) " Calibration Button (1 @) " Lead Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL)- UDI-DI
- 00850355006024
- Lot code
- ALL lots and ALL sublots;
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide and the countries of Argentina, Australia, Bhutan, Bolivia, Canada, Chile, Diego Garcia, Ecuador, Eritrea, Georgia, Ghana, Guam, Guatemala, Haiti, Hong Kong, India, Indonesia, Israel, Italy, Ivory Coast, Japan, Kyrgyzstan, Mexico, Nepal, Peru, Philippines, South Africa, South Korea, Spain, UAE, Uruguay, Vietnam.
- Company
- Magellan Diagnostics, Inc.North Billerica, Massachusetts
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98502
- Recall numbers
- Z-1893-2026 to Z-1895-2026
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
Summary updated
