Reported Jul 7, 2021 · Terminated
LeadCare II Blood Lead Test Kit Catalog Number 70-6762
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 II Blood Lead Test Kit Catalog Number 70-6762
- Lot codes and dates
- Lot Numbers/Expiration Date
2013M - 22APR222014M - 29APR222015M - 12MAY222016M - 19MAY222017M - 10JUN221st
- expansion 6/21/2021
2101M - 28JUL222103M - 18AUG222105M - 11SEP222106M - 21JAN222107M - 30SEP222nd expansion 8/30/20212012M
- Sublots
-08-09-10-11-12-13-14 - 08APR222018M - 06JUN222102M - 30SEP212109M - 15OCT222110M - 29OCT222111M - 31MAY222112M - 13NOV222113M - 30JUN222114M - 17DEC222115M - 29DEC227114M - 17DEC22
- Lot Numbers/Expiration Date
- Amount recalled
- 387,281 kits (48 tests/kit=1,757,040 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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