CLASS I Device recall · Reported 14 Jun 2017 · FDA Enforcement Report
LeadCare and LeadCare II test Kits recalled by Magellan Diagnostics
Magellan Diagnostics is recalling Magellan Diagnostics LeadCare and LeadCare II test Kits, distributed nationwide in the US. The recall was initiated on 23 May 2017 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-2225-2017
- FDA event ID
- 77211
- Recalling firm
- Magellan Diagnostics, North Billerica, MA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 23 May 2017
- FDA classified
- 5 Jun 2017
- Reported
- 14 Jun 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Test Kits & Diagnostics
Timeline
| 23 May 2017 | Recall initiated by company | |
| 5 Jun 2017 | Classified by FDA | +13 days |
| 14 Jun 2017 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems
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
Magellan Diagnostics LeadCare and LeadCare II test Kits. Product Usage: The LeadCare Blood Lead Test Kit is for in vitro diagnostic use only. The Test Kit is for the quantitative measurement of lead in fresh whole blood. This product is for professional use only. Sensors and Treatment Reagent of the Test Kit are specific for lead only. Contents of this LeadCare Blood Lead Test Kit must only be used with a LeadCare Analyzer and Blood Lead Testing System.
Where it was distributed
Worldwide Distribution - US (Nationwide) Foreign: AUSTRALIA AUSTRIA BOLIVIA CANADA CHILE CHINA COLOMBIA DOMINICAN REPUB ENGLAND GERMANY INDIA UK ISRAEL ITALY JAPAN KOREA MALI MYANMAR SPAIN NEPAL NETHERLANDS NEW ZEALAND P.R. CHINA PANAMA US PERU PHILLIPINES POLAND PORTUGAL REP OF KOSOVO SOUTH AFRICA SRI LANKA USA SWEDEN SWITZERLAND TRINIDAD UNITED ARAB EMI VIETNAM
Questions about this recall
Is LeadCare and LeadCare II test Kits recalled?
Yes. Magellan Diagnostics recalled LeadCare and LeadCare II test Kits on 23 May 2017. The recall is Class I and its status is Terminated. Recall number Z-2225-2017.
Why was it recalled?
Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems
Which lots are affected?
All lot codes
Where was it sold?
Worldwide Distribution - US (Nationwide) Foreign: AUSTRALIA AUSTRIA BOLIVIA CANADA CHILE CHINA COLOMBIA DOMINICAN REPUB ENGLAND GERMANY INDIA UK ISRAEL ITALY JAPAN KOREA MALI MYANMAR SPAIN NEPAL NETHERLANDS NEW ZEALAND P.R. CHINA PANAMA US PERU PHILLIPINES POLAND PORTUGAL REP OF KOSOVO SOUTH AFRICA SRI LANKA USA SWEDEN SWITZERLAND TRINIDAD UNITED ARAB EMI 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 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 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 | (2) LeadCare¿ II 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 |
| 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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