Z-0584-2026Class II

The LeadCare II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in whole...

Name: Z-0584-2026 The LeadCare II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in whole...
Creator: Magellan Diagnostics, Inc.
Published: 2024-02-23
License: https://open.fda.gov/license/

Magellan Diagnostics, Inc. / initiated 2024-02-23 / Open, Classified / root cause: labeling and UDI

FDA source

Magellan Diagnostics, Inc. began a recall of The LeadCare II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in whole blood. The LeadCare II Test Kit is provided with... on 2024-02-23. FDA classified it as Class II and gives the reason as "Calibration Buttons being used in the kitting process were incorrectly labeled as Lot 2323M for lot 2333M. The use of mislabeled calibration Button with Lot #2333 can lead to delayed or erroneous high or erroneous low...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0584-2026
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-23
Posted: 2025-11-21
Recalling firm: Magellan Diagnostics, Inc.
Product: The LeadCare II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in whole blood. The LeadCare II Test 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)
Product code: DOF Lead, Atomic Absorption
Reason for recall: Calibration Buttons being used in the kitting process were incorrectly labeled as Lot 2323M for lot 2333M. The use of mislabeled calibration Button with Lot #2333 can lead to delayed or erroneous high or erroneous low results.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: On March 3, 2024, MEDICAL DEVICE FIELD CORRECTION letters were sent to customers. Immediate Actions: 1. Identify existing inventory of impacted product and suspend its distribution. 2. Identify customers that received the impacted product and notify them about this field action. 3. Return remaining impacted product to Magellan Diagnostics, Inc. for destruction. To initiate the return process, ensure that you note the quantity of product to be returned on your Confirmation of Notification Form. Actions to Be Taken by Magellan: 1. Magellan Diagnostics will continue to investigate the cause of the labeling error and initiate appropriate preventive actions. 2. Magellan will replace unexpired impacted product upon request. Product will be replaced based on availability, and on a first-come first-served basis.
Quantity in commerce: 1,774 units
Distribution: US Nationwide distribution.
Product codes and lots: Product Name: LeadCare¿ II Blood Lead Test Kit; Catalog Number: 70-6762; Impacted Lot/Sublot Numbers: 2333M, 2333M-01, 2333M-02, 2333M-03, 2333M-04, 2333M-05, 2333M-06, 2333M-07, 2333M-08, 2333M-09, 2333M-10, 2333M-11; Device Identifier: (01)00850355006000;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0584-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0584-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-03	2025-11-21

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)