Magellan Diagnostics LeadCare Plus Blood Lead Test Kit Recall - False Positive Results

Class 2 Device Recall Magellan Diagnostics LeadCare Plus Blood Lead Test Kit

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| | Class 2 Device Recall Magellan Diagnostics 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) |
| Code Information | Catalog Number: 82-0004;
UDI-DI: 00850355006031;
ALL lots and ALL sublots; |
| FEI Number | 1218996 |
| Recalling Firm/
Manufacturer | Magellan Diagnostics, Inc.
101 Billerica Ave Bldg 4
North Billerica MA 01862-1271 |
| For Additional Information Contact | Magellan Diagnostics, Inc. Technical Services
800-272-0102 |
| Manufacturer Reason
for Recall | Customers reported observing 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. |
| FDA Determined
Cause | Device Design |
| Action | On March 13, 2026, MEDICAL DEVICE FIELD CORRECTION letters were sent to customers.
REQUIRED ACTIONS:
This field action does NOT require removal of product from the field. The LeadCare Test Systems continue to perform as intended when used according to the product labeling and Instructions for Use.
The regulatory status of all products noted above remains unchanged and the product supply uninterrupted. Technical and customer support will continue as normal.
LEADCARE II: The only blood collection devices validated for use with the Magellan LeadCare II Blood Lead Test Kit are the capillary tubes provided in the LeadCare II Test Kit. No other collection device should be used for blood sample collection for testing with the LeadCare II System.
LEADCARE PLUS AND ULTRA: End users must validate the use of micro-collection devices with LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems in accordance with their laboratory policies and procedures.
REGARDING PREVIOUS RESULTS: Patients who have had elevated results when tested on the LeadCare Blood Lead Test Systems (LeadCare II, LeadCare Plus, and LeadCare Ultra) should have confirmatory testing performed in accordance with CDC or other applicable standards and guidelines. |
| Quantity in Commerce | 136 |
| Distribution | 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. |
| Total Product Life Cycle | TPLC Device Report |

| 1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes. | |

| 510(K) Database | 510(K)s with Product Code = DOF |