RecallRadar

FDA Device recall Z-2088-2014

Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette

On 2014-07-30 the FDA classified a Class II recall of Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette by Itc Nexus Dx, citing test results may be erroneously elevated or report an out-of-range high (OOR-H) error code in non heparinized blood samples.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2088-2014
ClassificationClass II
Statusterminated
Initiated2014-06-20
Published2014-07-30
Last updated2026-09-13 11:53 UTC
CompanyItc Nexus Dx
DistributionGA, NY, VA

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.

Identifiers

code_infoLot Number A4JCA001

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2088-2014%22

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