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U.S. Department of Health and Human Services

Class 2 Device Recall LeadCare II Blood Lead Test Kit

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 Class 2 Device Recall LeadCare II Blood Lead Test Kitsee related information
Date Initiated by FirmFebruary 23, 2024
Date PostedNovember 21, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0584-2026
Recall Event ID 97858
510(K)NumberK052549 
Product Classification Lead, atomic absorption - Product Code DOF
ProductThe 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)
Code Information 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;
FEI Number 1218996
Recalling Firm/
Manufacturer		 Magellan Diagnostics, Inc.
101 Billerica Ave Bldg 4
North Billerica MA 01862-1271
For Additional Information ContactVernon Brown
800-305-0197
Manufacturer 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.
FDA Determined
Cause 2		Labeling mix-ups
ActionOn 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 Commerce1,774 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DOF
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