Reported Jul 18, 2012 · Terminated
Alere Triage CardioProfiler Panel PN 97100CP Used for the quantitative determination of creatine kinase MB, myoglobin,…
Alere San Diego, 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: Alere San Diego, Inc. · 9975 Summers Ridge Rd · San Diego, CA · 92121-2997
Is this the product you have?
- Alere Triage CardioProfiler Panel PN 97100CP Used for the quantitative determination of creatine kinase MB, myoglobin, troponin I and B-type natriuretic peptide in EDTA anticoagulated whole blood and plasma specimens.
- Lot codes and dates
- Phase 1
W49604BW49606BW49607BW49611BW49612BW49613BW49614BW49615BW49616BW49617BW49620BW49622BW49623BW49624BW49625BW49627BW49628BW49629BW49630BW49631BW49633BW49634BW49635BW49638BW49639BW50726BW50727BW50728BW50731BW50733BW50734BW50738Band W50739B
- Phase 2
W49609BW49610BW49618BW49619BW49626BW49632BW49640BW50737Band W50744B
- Phase 1
- Amount recalled
- 16,962 kits
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Certain lots of the affected products may have significantly decreased precision relative to the package insert, which could result in an increased frequency of false positive or false negative results. These false positive and false negative results are unpredictable within lots and may not be detected by Quality Control testing.
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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