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ITC-Nexus Dx recalls Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a
Recalled February 12, 2014 · FDA recall Z-0937-2014 · ITC-Nexus Dx
Hazard
ITC has determined that some Citrate APTT cuvettes may recover higher than expected results in normal individuals. · FDA Class II
Units
25,965 curvettes (7,425 cuvettes US; 18,540 cuvettes OUS)
Sold at
Worldwide Distribution: US (nationwide) and countries of: Austria, Belgium, Canada, Serbia, Germany, Estonia, Italy, Spain and Saudia Arabia.
Description
ITC has determined that some Citrate APTT cuvettes may recover higher than expected results in normal individuals.
Product
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.
Manufacturer(s)
ITC-Nexus Dx
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →