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Z-2088-2014 Class II Terminated

Recalled by ITC-Nexus Dx — Edison, NJ

FDA device recall Z-2088-2014 was initiated by ITC-Nexus Dx on June 20, 2014 and is designated Class II. 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. The recall status is terminated (terminated December 11, 2014). Affected quantity: US- 315 cuvettes; OUS - 2835 cuvettes.

Recall Details

Product Type: Devices
Report Date: July 30, 2014
Initiation Date: June 20, 2014
Termination Date: December 11, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: US- 315 cuvettes; OUS - 2835 cuvettes

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.

Distribution Pattern

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

Code Information

Lot Number A4JCA001