CLASS II ONGOING Device recall · Reported 29 Apr 2026 · FDA Enforcement Report
(2) LeadCare¿ II Blood Lead Test Kit recalled by Magellan Diagnostics
Magellan Diagnostics is recalling (2) LeadCare¿ II Blood Lead Test Kit, LeadCare¿ II 5X Blood Lead Test Kit, LeadCare¿, 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-1893-2026
- 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
- Lead & Heavy Metals
- 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.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
(1)(2) LeadCare¿ II Blood Lead Test Kit, (3)LeadCare¿ II 5X Blood Lead Test Kit, (4)LeadCare¿ II 9X Blood Lead Test Kit ; Catalog Number(s): (1) 70-6762, (2) 70-6762RUO, (3) 70-8404 (Box containing 5 Test Kits), (4) 70-9000 (Box containing 9 test kits); The LeadCare II kit is provided with the following materials: " Sensors (2 Containers of 24 sensors each; 48 tests) " Treatment Reagent Tubes (2 packages of 24 tubes each; 48 tests) " Heparinized Capillary Tubes/Plungers (50 @) " Transfer Droppers (50 @) " 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
Is (2) LeadCare¿ II Blood Lead Test Kit, LeadCare¿ II 5X Blood Lead Test Kit, LeadCare¿ recalled?
Yes. Magellan Diagnostics recalled (2) LeadCare¿ II Blood Lead Test Kit, LeadCare¿ II 5X Blood Lead Test Kit, LeadCare¿ on 13 Mar 2026. The recall is Class II and its status is Ongoing. Recall number Z-1893-2026.
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(s): (1) 70-6762, (2) 70-6762RUO; UDI-DI: 00850355006000; ALL lots and ALL sublots; Catalog Number(s): (3) 70-8404; UDI-DI: 00850355006086; ALL lots and ALL sublots; Catalog Number(s): (4) 70-9000; UDI-DI: 00850355006093; 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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Magellan Diagnostics
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | LeadCare Ultra Blood Lead Test Kit recalled by Magellan Diagnostics | Magellan Diagnostics | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | LeadCare¿ Plus Blood Lead Test Kit recalled by Magellan Diagnostics | Magellan Diagnostics | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | The LeadCare¿ II Blood Lead Test System relies on recalled | Magellan Diagnostics | Labeling Errors | Nationwide |
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