Z-1895-2026Class II

LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the...

Name: Z-1895-2026 LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the...
Creator: Magellan Diagnostics, Inc.
Published: 2026-03-13
License: https://open.fda.gov/license/

Magellan Diagnostics, Inc. / initiated 2026-03-13 / Open, Classified / root cause: design

FDA source

Magellan Diagnostics, Inc. began a recall of 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... on 2026-03-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1895-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-13
Posted: 2026-04-17
Recalling firm: Magellan Diagnostics, Inc.
Product: 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)
Product code: DOF Lead, Atomic Absorption
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.
Root cause tag: design
FDA root 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: 284
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 codes and lots: Catalog Number: 70-8098; UDI-DI: 00850355006024; ALL lots and ALL sublots;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1895-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1893-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-17
Z-1894-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-17
Z-1895-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-17

Product code DOF

K052549Class IILeadcare II Blood Lead Testing SystemEsa Biosciences, Inc. / cleared 2005-10-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)