Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to ...
FDA Recall #Z-0937-2014 — Class II — December 19, 2013
Product Description
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.
Reason for Recall
ITC has determined that some Citrate APTT cuvettes may recover higher than expected results in normal individuals.
Recalling Firm
ITC-Nexus Dx — Edison, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
25,965 curvettes (7,425 cuvettes US; 18,540 cuvettes OUS)
Distribution
Worldwide Distribution: US (nationwide) and countries of: Austria, Belgium, Canada, Serbia, Germany, Estonia, Italy, Spain and Saudia Arabia.
Code Information
E3JCC013-P1 - exp 2014-05 E3JCC014-P2 - exp - 2014-05 F3JCC015-P3 - exp -2014-06 F3JCC016 - exp - 2014-06 H3JCC017 - exp - 2014-08
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated