FDA-Device2014-02-12Class II
Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individual patient heparin sensitivity.
ITC-Nexus Dx
Hazard
ITC has determined that some Citrate APTT cuvettes may recover higher than expected results in normal individuals.
Sold states
Worldwide Distribution: US (nationwide) and countries of: Austria, Belgium, Canada, Serbia, Germany, Estonia, Italy, Spain and Saudia Arabia.
Affected count
25,965 curvettes (7,425 cuvettes US; 18,540 cuvettes OUS)
Manufactured in
23 Nevsky St, Edison, NJ, United States
Products
Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individual patient heparin sensitivity.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0937-2014Don't want to check this manually?
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