CLASS I Device recall · Reported 7 Jul 2021 · FDA Enforcement Report
LeadCare II Blood Lead Test Kit recalled by Magellan Diagnostics
Magellan Diagnostics is recalling LeadCare II Blood Lead Test Kit, distributed nationwide in the US. The recall was initiated on 7 May 2021 and the FDA has classified it as Class I.
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-1952-2021
- FDA event ID
- 87992
- Recalling firm
- Magellan Diagnostics, North Billerica, MA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 7 May 2021
- FDA classified
- 1 Jul 2021
- Reported
- 7 Jul 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 7 May 2021 | Recall initiated by company | |
| 1 Jul 2021 | Classified by FDA | +55 days |
| 7 Jul 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may cause the underestimation of blood lead levels in patient samples.
Product as listed by the FDA
LeadCare II Blood Lead Test Kit Catalog Number 70-6762
Where it was distributed
Worldwide distribution. US nationwide including Puerto Rico; Canada, Vietnam, India, Italy, Peru, New Zealand, Australia, Hong Kong, and Philippines.
Questions about this recall
Why was it recalled?
Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may cause the underestimation of blood lead levels in patient samples.
Which lots are affected?
Lot Numbers/Expiration Date: 2013M - 22APR22; 2014M - 29APR22; 2015M - 12MAY22; 2016M - 19MAY22; 2017M - 10JUN22; 1st expansion 6/21/2021: 2101M - 28JUL22; 2103M - 18AUG22; 2105M - 11SEP22; 2106M - 21JAN22; 2107M - 30SEP22; 2nd expansion 8/30/2021; 2012M Sublots: -08, -09, -10, -11, -12, -13, -14 - 08APR22; 2018M - 06JUN22; 2102M - 30SEP21; 2109M - 15OCT22; 2110M - 29OCT22; 2111M - 31MAY22; 2112M - 13NOV22; 2113M - 30JUN22; 2114M - 17DEC22; 2115M - 29DEC22; 7114M - 17DEC22.
Where was it sold?
Worldwide distribution. US nationwide including Puerto Rico; Canada, Vietnam, India, Italy, Peru, New Zealand, Australia, Hong Kong, and Philippines.
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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 87992This product is part of a recall event; the main page for the event is LeadCare Ultra Blood Lead Test Kit recalled by Magellan Diagnostics.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | LeadCare Ultra Blood Lead Test Kit recalled by Magellan Diagnostics | Magellan Diagnostics | Other | Nationwide | |
| CLASS I | LeadCare Plus Blood Lead Test Kit recalled by Magellan Diagnostics | Magellan Diagnostics | Other | Nationwide |
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 | Device Malfunction | Nationwide |
| 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 |
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