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1)(2) LeadCare II Blood Lead Test Kit, (3)LeadCare II 5X… recallZ-1893-2026 · Magellan Diagnostics, Inc. · initiated Mar 13, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Magellan Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-1893-2026
Status
Open, Classified
Initiated by the company
Mar 13, 2026
Posted by the FDA
Apr 17, 2026
Recalling firm
Magellan Diagnostics, Inc.
Quantity
197893
Product code
DOF
FDA submissions
K052549
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.

Product description

(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)

Code information (models, lots, serial numbers)

Catalog Number(s): (1) 70-6762, (2) 70-6762RUO; UDI-DI: 00850355006000; 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;

Devices named in this recall

3 devices in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

2 devices cleared under K052549 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 98502).

Sources and updates

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