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Alere San Diego, Inc. recalls Alere Triage BNP PN 98000XR Intended to be used as an aid in the diagnosis and assessment of severity of congestive h
Recalled July 18, 2012 · FDA recall Z-1931-2012 · Alere San Diego
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. · FDA Class I
Units
30,083 kits
Sold at
Nationwide Distribution
Description
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.
Product
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).
Manufacturer(s)
Alere San Diego, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →