Reported Apr 29, 2026 · Ongoing
LeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare¿ Plus kit is provided with the following…
Magellan Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Magellan Diagnostics, Inc. · 101 Billerica Ave Bldg 4 · North Billerica, MA · 01862-1271
Is this the product you have?
5 of 5 products
| Model / number | Product as published |
|---|---|
| — | LeadCare¿ Plus Blood Lead Test Kit |
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 Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL) |
- Lot codes and dates
- Catalog Number82-0004
- UDI-DI00850355006031; ALL lots and ALL sublots
- Amount recalled
- 136
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- GA
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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