Recall Z-2088-2014— ITC-Nexus Dx

Name: FDA recall Z-2088-2014
Creator: U.S. Food and Drug Administration
Published: 2014-06-20

Class II · Terminated

Class II FDA medical device recall by ITC-Nexus Dx, initiated 2014-06-20, terminated 2014-12-11. It names one FDA 510(k) clearance: K940401. Product: Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.. Reason: Test results may be erroneously elevated or report an out-of-range high (OOR-H) error code in non heparinized blood samples..

Recalling firm: ITC-Nexus Dx
Classification: Class II
Status: Terminated
Initiated: 2014-06-20
Terminated: 2014-12-11
Firm location: Edison, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K940401 — JR. MICROCOAGULATION SYSTEMInternational Technidyne Corp.·cleared 1994-05-11

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.