FDA-Device2012-07-18Class I
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.
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
1,972 kits
Manufactured in
9975 Summers Ridge Rd, San Diego, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1932-2012Don't want to check this manually?
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