Reported May 24, 2017 · Terminated
Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010
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
- Ultra Blood Lead Test Kits Part Number80-0010
- Lot codes and dates
- Kit lots
1309BU1310AU1312BU1404AU1408BU
- Kit lots
- Amount recalled
- 1016
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
LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concentrations in some blood samples. The issue is observed when blood samples are collected in tubes with lavender and tan rubber stoppers of the Becton Dickinson EDTA Vacutainer tubes, a collection device used with the testing system.
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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