Reported Jul 7, 2021 · Terminated
LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098
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?
- LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098
- Lot codes and dates
- Lot Numbers/Expiration Date2011MU - 25MAR22. 1st
- expansion 6/21/2021
2104MU - 25AUG222108MU - 31MAR22
- Amount recalled
- 441 kits (192 tests/kit = 84,672 tests)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
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.
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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