LeadCare Plus Blood Lead Test Kit Recalled for Unexpectedly Elevated Results
Magellan Diagnostics is recalling LeadCare Plus Blood Lead Test Kits (Catalog Number 82-0004) because they may produce falsely elevated lead results when used with certain third-party micro-collection devices, potentially causing delayed testing and unnecessary follow-up testing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall of a medical device that produces false positive results for a risk-of-harm hazard (inaccurate lead testing affecting clinical decision-making), but no illnesses or injuries are reported in the source text. The false results create a risk of unnecessary testing and delayed accurate diagnosis, which meets the High criteria for risk-of-harm products without reported adverse outcomes.
Plain-English summary
Magellan Diagnostics, Inc. is recalling the LeadCare Plus Blood Lead Test Kit (Catalog Number 82-0004) used for testing capillary blood samples. The recall affects all lots and sublots (UDI-DI: 00850355006031) distributed worldwide, including across the US and internationally to 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, and Vietnam.
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.
Consumers and healthcare facilities who have the LeadCare Plus Blood Lead Test Kit should contact Magellan Diagnostics, Inc. for further guidance on the recall and any affected test kits in their possession.
The recalled product
- Product
- LeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare¿ Plus kit is provided with the following materials: " Sensors (4 containers of 24 each; 96 tests) " Treatment Reagent Tubes (4 packages of 24 each; 96 tests) " Calibration Button (1 @) " Lead…
- Manufacturer
- Magellan Diagnostics, Inc.
- Affected units
- 136
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 (3)
- Catalog Number: 82-0004
- UDI-DI: 00850355006031
- ALL lots and ALL sublots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Magellan Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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