ITC-Nexus Dx: Medical Device Recall in 2014 - (Recall #: Z-2088-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 20, 2014

Date Posted: July 30, 2014

Recall Number: Z-2088-2014

Event ID: 68659

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.

Status: Terminated

Product Quantity: US- 315 cuvettes; OUS - 2835 cuvettes

Code Information:

Lot Number A4JCA001

Distribution Pattern:

Worldwide Distribution - US including the states of Georgia, Virginia and New York., and the countries of Canada, France, Italy, Liechtenstein and Romania.

Voluntary or Mandated:

Voluntary: Firm initiated