Magellan LeadCare II Blood Lead Test Kit Recall for Labeling Error
Magellan Diagnostics is recalling 321 LeadCare II Blood Lead Test Kits due to a potential expiration date labeling error that may delay test results.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall addresses a labeling error that prevents test execution, causing delayed results but no direct health hazard. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Magellan Diagnostics, Inc. is recalling 321 units of the LeadCare II Blood Lead Test Kit, Model/Catalog Number 70-6762, Lot Number 2530M-01. The recall is due to a labeling error where the outer packaging may display an incorrect expiration date of July 22, 2026, instead of the correct date of July 13, 2026.
The affected kits were distributed nationwide in California, Indiana, Pennsylvania, Texas, Nebraska, Illinois, Massachusetts, Missouri, and Kentucky. If a kit with the incorrect expiration date is used, the system will display an error message and prevent the operator from running the test, resulting in delayed results.
Consumers and healthcare providers should stop using the affected kits and contact Magellan Diagnostics for further instructions.
The recalled product
- Product
- LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762.
- Manufacturer
- Magellan Diagnostics, Inc.
- Hazard
- Affected units
- 321
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model/Catalog Number: 70-6762. UD-DI: 00850355006000. Lot Number. 2530M-01.
Distribution
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