Reported Jun 14, 2017 · Terminated
Magellan Diagnostics LeadCare and LeadCare II test Kits. Product Usage: The LeadCare Blood Lead Test Kit is for in…
Magellan Diagnostics, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.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?
- Magellan Diagnostics LeadCare and LeadCare II test Kits
- Product UsageThe 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
- Lot codes and dates
- All lot codes
- Amount recalled
- 171,979 kits (total)= 153,447 (US)and 18532 (OUS)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems
Using this product could cause serious injury, illness or death — stop using it now.
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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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