🔍 RecallPedia

ITC-Nexus Dx

3 recalls •

🏥 Medical Devices

• Categories: Diagnostic Equipment, Surgical Instruments

Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.

Class I - Dangerous

Test results may be erroneously elevated or report an out-of-range high (OOR-H) error code in non heparinized blood samples.

Jun 20, 2014 Diagnostic Equipment View Details →

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.

Class I - Dangerous

ITC has determined that some Citrate APTT cuvettes may recover higher than expected results in normal individuals.

Dec 19, 2013 Diagnostic Equipment Nationwide View Details →

Surgicutt fully automated incision making device for bleeding time determination. ITC 8 Olsen Avenue, Edison, NJ 08820. 732.548.5700. www.itcmed.com. A subsidiary of Thoratec Corporation. The device is a spring loaded cam driven device that provides standardized incisions of 5 mm length and 1 mm depth. This fully automated instrument is used along with blotting paper for bleeding time determinations.

Class I - Dangerous

ITC has determined that the blade in their Surgicutt with Blotting Paper (Product Code: SUB50I; Lot: AK301M) devices may be loose.

Aug 22, 2013 Surgical Instruments Nationwide View Details →