FDA-Device2012-07-18Class I
Alere Triage BNP PN 98000XR Intended to be used as an aid in the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure).
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
30,083 kits
Manufactured in
9975 Summers Ridge Rd, San Diego, CA, United States
Products
Alere Triage BNP PN 98000XR Intended to be used as an aid in the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1931-2012Don't want to check this manually?
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