Home / Recalls / ITC-Nexus Dx / Z-0937-2014

Z-0937-2014 Class II Terminated

Recalled by ITC-Nexus Dx — Edison, NJ

Recall Details

Product Type: Devices
Report Date: February 12, 2014
Initiation Date: December 19, 2013
Termination Date: October 30, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 25,965 curvettes (7,425 cuvettes US; 18,540 cuvettes OUS)

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.

Distribution Pattern

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