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U.S. Department of Health and Human Services

Class 3 Device Recall LeadCare II

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 Class 3 Device Recall LeadCare IIsee related information
Date Initiated by FirmSeptember 04, 2026
Date PostedOctober 15, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0162-2027
Recall Event ID 99776
510(K)NumberK052549 
Product Classification Lead, atomic absorption - Product Code DOF
ProductLeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762.
Code Information Model/Catalog Number: 70-6762. UD-DI: 00850355006000. Lot Number. 2530M-01.
FEI Number 1218996
Recalling Firm/
Manufacturer		 Magellan Diagnostics, Inc.
101 Billerica Ave Bldg 4
North Billerica MA 01862-1271
For Additional Information ContactRyan Spradling
1-800-2750102
Manufacturer Reason
for Recall		In kit sub-lot 2530M-01 the date of expiration printed on the outer labeling may indicate the wrong expiration date of July 22, 2026 while the correct expiration date is July 13, 2026. If used the system will display an error message and prevent the operator from running the test. Resulting in delayed results.
FDA Determined
Cause 2		Labeling Change Control
ActionMagellan notified consignees on about September 4, 2026, via telephone call indicating a written notification of the recall would follow. On 09/17/2026, a notification letter was emailed to consignees with the following instructions: 1. Complete, sign, and return the CONFIRMATION OF NOTIFICATION FORM. 2. Review your inventory for the affected LeadCare II Blood Lead Test Kit lot identified. 3. Immediately discontinue use of any remaining affected kits. 4. Return any recalled product still in your possession to Magellan Diagnostics, Inc. for destruction.
Quantity in Commerce321 units
DistributionUS Nationwide distribution in the states of CA, IN, PA, TX, NE, IL, MA, MO, KY.
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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