CLASS II ONGOING Device recall · Reported 29 Apr 2026 · FDA Enforcement Report
LeadCare Ultra Blood Lead Test Kit recalled by Magellan Diagnostics
Magellan Diagnostics is recalling LeadCare Ultra Blood Lead Test Kit, distributed nationwide in the US. The recall was initiated on 13 Mar 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1895-2026
- FDA event ID
- 98502
- Recalling firm
- Magellan Diagnostics, North Billerica, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 Mar 2026
- FDA classified
- 17 Apr 2026
- Reported
- 29 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 13 Mar 2026 | Recall initiated by company | |
| 17 Apr 2026 | Classified by FDA | +35 days |
| 29 Apr 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the following materials: " Sensors (8 containers of 24 each; 192 tests) " Treatment Reagent Tubes (8 containers of 24 each; 192 tests) " Calibration Button (1 @) " Lead Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL)
Where it was distributed
Worldwide - US Nationwide and the countries of 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, Vietnam.
Questions about this recall
Why was it 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.
Which lots are affected?
Catalog Number: 70-8098; UDI-DI: 00850355006024; ALL lots and ALL sublots;
Where was it sold?
Worldwide - US Nationwide and the countries of 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, Vietnam.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 98502This product is part of a recall event; the main page for the event is LeadCare¿ Plus Blood Lead Test Kit recalled by Magellan Diagnostics.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | LeadCare¿ Plus Blood Lead Test Kit recalled by Magellan Diagnostics | Magellan Diagnostics | Packaging Defects | Nationwide | |
| CLASS II | (2) LeadCare¿ II Blood Lead Test Kit recalled by Magellan Diagnostics | Magellan Diagnostics | Packaging Defects | Nationwide |
More recalls from Magellan Diagnostics
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | (2) LeadCare¿ II Blood Lead Test Kit recalled by Magellan Diagnostics | Magellan Diagnostics | Packaging Defects | Nationwide |
| Device | CLASS II | LeadCare¿ Plus Blood Lead Test Kit recalled by Magellan Diagnostics | Magellan Diagnostics | Packaging Defects | Nationwide |
| Device | CLASS II | The LeadCare¿ II Blood Lead Test System relies recalled | Magellan Diagnostics | Labeling Errors | Nationwide |
| Device | CLASS II | LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only recalled | Magellan Diagnostics | Foreign Material | Nationwide |
| Device | CLASS I | LeadCare II Blood Lead Test Kit recalled by Magellan Diagnostics | Magellan Diagnostics | Other | Nationwide |
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