FDA-Device2012-07-18Class I
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.
Alere San Diego, Inc.
Hazard
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.
Sold states
Nationwide Distribution
Affected count
5,013 kits
Manufactured in
9975 Summers Ridge Rd, San Diego, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1930-2012Don't want to check this manually?
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