Recall Z-0937-2014— ITC-Nexus Dx
Class II · Terminated
Class II FDA medical device recall by ITC-Nexus Dx, initiated 2013-12-19, terminated 2014-10-30. It names one FDA 510(k) clearance: K014008. 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.. Reason: ITC has determined that some Citrate APTT cuvettes may recover higher than expected results in normal individuals..
- Recalling firm
- ITC-Nexus Dx
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-12-19
- Terminated
- 2014-10-30
- Firm location
- Edison, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.