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Alere San Diego, Inc. recalls Triage D-dimer PN 98100 Used as an aid in the assessment and evaluation of patients suspected of having disseminated
Recalled July 18, 2012 · FDA recall Z-1932-2012 · 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
1,972 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
Triage D-dimer PN 98100 Used as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism.
Manufacturer(s)
Alere San Diego, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →