Reported Jul 18, 2012 · Terminated
Alere Triage Profiler SOB Panel PN 97300 Used for the determination of creatine kinase MB, myoglobin, troponin I,…
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 Profiler SOB Panel PN 97300 Used for the determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peptide, and cross-linked fibrin degradation products containing D-dimer in EDTA anticoagulated whole blood and plasma specimens.
- Lot codes and dates
- Phase 1
K50708BW50009BW50011BW50012BW50013BW50014BW50016VBW50021BW50026BW50028BW50030BW50771BW50772BW50773BW50774BW50778Band W50801B
- Phase 2
W50015BW50029Band W50788B
- Phase 1
- Amount recalled
- 5,013 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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